1．3．2 外国における不具合の発現状況 （1）MDR にて報告された
Contents
1. 23 303 E secu 2 10 41 303 52. 35
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4. 2 Cyberonics 2 PDA 2 2 2 2 a 40ms b 2 PDA Retry ae
5. a a 30 3 250 Dell X5 2A a E He 3 ALS a E ma Ea 4 Microsoft Dell Cyberonics
6. 1 Aw 0 Lead fractures of the VNS Therapy System may prevent patients from receiving therapy If a Lead fracture is suspected perform diagnostic testing per the Physician s Manual to evaluate continuity within the system If diagnostics suggest that a fracture is present c
7. PDA 31 2q APA BPAN Field Safety Notice 1 AR Cyberonics 2 Field Safety Notice
8. 2 n Aas ody Ea BB BE EE NE n gt so ck Sk CP WAY 0 1 0 0 0 0 0 08 0 08 0 08 0 08 0 0 0 08 0 08 0 08 0 0 0 1 0 0 0 08 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 0 0 08 0 08 0 08 0 0 0 0 0 08 0 0 0 08 0 08 0 08 0 0 0 08 0 08 0 08 0 0 0 08 0 0 0 0 100 0 12 1 2 2 2 ABA E COMICHBEL KAY AT ADKREORERG 28 om HON WAY gt
9. Q20 EE O E 2 1 20 AERA BBD Field Safety Notice 7 1 Model 250 OK 2 Model 250 VNS Therapy Programming M250 Programming System 4 6 6 1 7 0 TA NRK ES 3 Cyberonics
10. D PAP ERs 1 2 ASC Cyberonics 103 104 2 RTR 2 2 Cyberonics
11. 3 IEMA EF NVA 103 104 2 20 Mo Ge Dal Imes Mo ke A lee ai RACH OB GAA 4 EOW 1 2
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13. Oma 2 1 2 Cyberonics 302 U 303 303
14. 2 20 BPA BBP Cyberonics 5 300 302 2 303
15. SN 3600 25 20 EAP
16. 2 2 19 CONTRAINDICATION Do not use short wave microwave diathermy or therapeutic ultrasound diathermy hereafter referred to as diathermy on patients implanted with a NeuroCybernetic Pr
17. N 2 VNS Therapy Demipulse Model 103 Generator VNS Therapy Demipulse Duo Model 104 Generator 34 3 Cyberonics Inc YVbat EBOS meee ELT lt gt
18. 100 102R DC DC 0 DC DC 0 1 7kQ 100 102R 103 104 a a 2009 2 VNS Therapy Pulse Generator 2 VNS Therapy Model 250 Programming System ee A tne 7 3 HIEDNA
19. oO 1 6 2 1 5 2 1 2 1 1 0 1 1 0 1 0 9 1 0 8 1 0 4 1 0 3 0 0 3 0 0 3 0 3 0 3 0 0 0 EOS EOS solelelelele 0 3 0 0 0 3 0 0 0 3 0 0 0 3 0 0 0 2 0 0 0 2 0 0
20. 27 2 8 0mA 5 O19 APA BAN 1 AES 19M AEE A BBP Cyberonics FDA 250 5 0
21. O2 ABP ABPAN Field Safety Notice 1 ACHE 20 FB BPA C2 1k 20 SEB BBP Field Safety Notice 50 AR A NIR RG
22. 2 2 9 9 2 1 20 Cyberonics 100 101 300 18 2 Oregon Health Sciences University OHSUU 20 FE Alc 2s
23. 3 250 3 8 4 NYB NYB 100
24. xe aR HEZIT o T ERED WAY 2 0 5 0 1 0 5 0 1 0 1 0 1 0 1 0 4 0 0 0 0 0 0 0 0 0 4 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 a 2 2 20 20 Ha WAY tRAV H A Fi OAM COM 20 0 2 0 1 0 0
25. Field Safety Notice 20 FE E 32 4 1 2 2 F OK 700 Q Dk DIVE T X
26. 2 Microsoft Dell API 2007 cus B
27. 1 2 2 FDA 2 3 Dell X50 PDA 20 4 2 5 20 FBP ABA 5 Cyberonics
28. 2 33 4 Field Safety Notice 2
29. 3 4 RT ee ee 5 R 26 O2G FB IBA EERE 1 209 FB 5 BBB 1G Cyberonics 250 6 1 7 0 7 1 9 8 0mA
30. 3 gt Cyberonics 28 2 250 3 8 30 1 5 3
31. 12mA FDA 3 5mA 3 5mA 3 IER Cyberonics IltemNumber DESCRIPTION Total US OUTSIDE US Comp HHD m250 v6 1 SP HH Com Box Canada Comp HHD m250 v6 1 7 Comp HH m250 v6 1 7 Comp HHD m250 v7 0 AComp HH m250 v7 1 Comp HHD m250 v6 1 7 INV Comp HHD m250 v6 0 4 1 retry RAY 3
32. 3 303 2 1 5 5 4 1 3 EF IVA 302 303 Hise 2A OARS E is BB 2 20 a TRA CH OB HAA kl W 4
33. 24 FEMA BIGHT S OVER A BP 5 Cyberonics
34. 1 3 E05 HTGH 1 1 1 Bil Low 0 0 0 HIGH 25 3 24 Bil Low 10 7 11 2 F 2q 2 E05 N F 2 2 Eo Fc SB FEES 0 0 0 1 15 OSA
35. 0SA OSA OSA m 20 ERA BPA 5 2G FBSA BP 1 3 2 J amp H 20 ARPA 0 0 Oa oe 51 7 6 3 9 2 1 1 6 3 0 8 5 1 0 6 4 2 0 5 2 5 0 3 2 5 0 3 2 5 0 3 2 1 0 3 0 0 0 0 0 0 kusar yy H Rails F S xr A up x
36. 0 2 KA AYES EFE BRUREORETR LEWD BHO CIC 20 ARPA EF 2 Alc FDA MDR Report No 1644487 2006 00221 2 rn 2 RK Cyberonics x a
37. 2 2 0 1 Ei Wry HR 40bpm
38. 0 2 0 0 EOS 0 2 0 0 0 2 0 0 16 GHK Y US HE A 270 E 9 E
39. 3 FIER 250 5 0 Lot No QuantityDistributed C 29 4 Dd FEE Eo 1 K 20 FB A BBE Cyberonics 250 7 1 4 Dell X5 PDA FDA Del1 X50 PDA
40. Cyberonics 1 EOS 2 3 4 NYB 2 1 EOS EOS
41. 1 303 POWAD ERM ETEA BAEC REBUY TC Cyberonics 302 303 2 PMA S 078 20 4E A E 3 2 _ Cyberonics ftit 20 FBP A BPA
42. MP AAT J A FINIDO BRIE LF 1 20 E 303 BEA Cyberonics F3 FR MP AS BBR 300 302
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45. 3 2 1 MDR MDR 19 20 MDR 2 FAA 2 20 2 K 1 3 1 k EEPO Ga BE 2 0 MM Cl Ca oo 27 1 3 2 SUDEP
46. 303 2B 2 ae 20M 20 2 Safety Notice a ere lg 1 3 2 2 0 2q ARAB k Field Safety Notice 20 2
47. Deep Brain Stimulator DBS CHS COR Cyberonics x GHD o 2028 OER Io OK UPD A BACB DORBGREAEL VTF 8 0C 14 4 DD 19 3 C 34 7 F Cyberonics 20 FDA 3
48. 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 Dun eee 0 1 0 0 MRI POPE 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 RE 0 1 0 0 MZ UEIE IAA 0 1 0 0 XE 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 E 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 FESS 0 0 Ee 0 0 0 0 0 0 0 0 0 0 0 0 lt r cae ATLA 0 0 0 0 0 0 RJAR 0 0 0 0 0 0 DEMA 0 0 0 0 tI 0 0 0 0 13 NRS r H 2005 2006 2007 2008 2009 pe Fe 0 0 0 0 fee 0 0 0
49. 0 0 0 0 0 tie 0 0 0 0 RI ROPE 0 0 FER 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 EHR Bis 0 0 0 0 aad 0 0 0 0 0 0 0 0 0 0 0 0 PE SENEE 0 0 A 0 0 0 0 100 0 11 7 E 0 FE 20 nd 2 E 2 PE 27 1 12 6 QR Be 4 4 E 3 8 QP a 3 7 QJ 3 3 SUDEP ay 3 2
50. e any short w diathermy microwave diathermy or therapeutic ultrasound diathermy hereafter referred ei as diathermy anywhere on your body because you have an implanted NeuroCybernetic Prosthesis NCP System sometimes referred to as a Vagus Nerve Stimulator or Vagus Nerve Stimulation or VNS Diagnostic ultrasound is not included in this contraindication Diathermy is a treatment to promote healing or relieve pain that is provided by special medical equipment ore equipment in a physician s office or dentist s office or other healthcare office Energy from diathermy therapy may cause heating of the NCP System The heating of the NCP System resulting from diathermy can cause temporary or permanent nerve or tissue or vascular damage This damage may result in pain or discomfort loss of vocal cord function or even possibly death if there is damage to blood vessels Diathermy may also damage parts of your NCP System This can result in loss of therapy from your NCP System and may require additional surgery to remove or replace parts of your implanted device Injury or damage can occur during diathermy treatment whether your NCP System is turned on or off 20 220 Fl bd 4 STERA
51. onsider turning the VNS Pulse Generator to zero milliamps 0 mA of output current Continuing stimulation with a fractured Lead may result in dissolution of the conductor material resulting in adverse events such as pain inflammation and vocal cord dysfunction The benefits and risks of leaving the Pulse Generator ON actively stimulating when a Lead fracture is present should be evaluated and monitored by the medical professional treating the patient 2 303 FDA 3 FA B Ce 4 Cyberonics i QB CBEST FRR SSS RITE 1 22 Cyberonics 5 Cyberonics
52. osthesis NCP System Diagnostic ultrasound is not included in this contraindication Energy delivered by diathermy may be concentrated into or reflected by implanted products such as the NCP System This concentration or reflection of energy may cause heating Testing indicates that diathermy can cause heating of the NCP System well above temperatures required for tissue destruction The heating of the NCP System resulting from diathermy can cause temporary or permanent nerve or tissue or vascular damage This damage may result in pain or discomfort loss of vocal cord function or even possibly death if there is damage to blood vessels Because diathermy can concentrate or reflect its energy off any size implanted object the hazard of heating is possible when any portion of the NCP System remains implanted including just a small portion of the lead or electrode Injury or damage can occur during diathermy treatment whether the NCP System is tumed on or off Diathermy is further prohibited because it may also damage the NCP System components resulting in loss of therapy requiring additional surgery for system explanation and replacement All risks associated with surgery or loss of therapy loss of seizure control would then be applicable Advise your patients to inform all their health care professionals that they should not be exposed to diathermy treatment CONTRAINDICATION Inform anyone treating you that you CANNOT hav
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