MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; Permanent Defibrillator Electrodes

Model Number	0276
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Electric Shock (2554); Shock from Patient Lead(s) (3162)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) and right ventricular (rv) defibrillation lead exhibited significant noise with oversensing since december 2016, resulting in an inappropriate shock and inappropriate atp.More recently, this oversensed noise resulted in an inappropriate burst of atp and greater than two seconds of pacing inhibition.It was unclear whether the patient was pacer dependent as the device rv paced 1%.Technical services (ts) reviewed possible causes and troubleshooting options, and possible lead integrity concerns were discussed.This icd system remains in service, however further evaluation was recommended.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: Permanent Defibrillator Electrodes
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 17278898
• Report Number: 2124215-2023-35670
• Device Sequence Number: 5086338
• Product Code: NVY
• UDI-Device Identifier: 00802526531231
• UDI-Public: (01)00802526531231(17)150619
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/19/2015
• Device Model Number: 0276
• Device Catalogue Number: 0276
• Device Lot Number: 101852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male