MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; IMPLANTABLE LEAD

Model Number	0175
Medical Device Problem Codes	High impedance (1291); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a follow up, this implantable cardioverter defibrillator (icd) was interrogated and noted to have recorded episodes of shock therapy.The health care professional (hcp) reviewed an episode and observed that code 1005 had been recorded.Technical services (ts) was contacted for further review of the stored data.Ts reviewed the provided data and confirmed that code 1005 which indicated an open circuit condition was detected during shock delivery was recorded.It was noted that the device had appropriately delivered a shock to convert patient rhythm, however during the delivery of the shock, high out of range right ventricular (rv) lead shock impedances that measured to be greater than 125 ohms were reported.Ts discussed possible cause and recommended for the icd and rv lead to be replaced.At this time, the icd and rv lead remain in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during a follow up, this implantable cardioverter defibrillator (icd) was interrogated and noted to have recorded episodes of shock therapy.The health care professional (hcp) reviewed an episode and observed that code 1005 had been recorded.Technical services (ts) was contacted for further review of the stored data.Ts reviewed the provided data and confirmed that code 1005 which indicated an open circuit condition was detected during shock delivery was recorded.It was noted that the device had appropriately delivered a shock to convert patient rhythm, however during the delivery of the shock, high out of range right ventricular (rv) lead shock impedances that measured to be greater than 125 ohms were reported.Ts discussed possible cause and recommended for the icd and rv lead to be replaced.At this time, the icd and rv lead remain in service.No additional adverse patient effects were reported.Subsequent additional information was received that reported during a follow up visit, the right ventricular automatic threshold (rvat) was detected to be greater than programmed amplitude or suspended.Technical services (ts) discussed programming options and recommended for the rv lead to be replaced.At this time, the rv lead remains in service.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE LEAD
• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24299000
• Report Number: 2124215-2026-07270
• Device Sequence Number: 21184258
• Product Code: LWS
• UDI-Device Identifier: 00802526373732
• UDI-Public: (01)00802526373732(17)120216
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/16/2012
• Device Model Number: 0175
• Device Catalogue Number: 0175
• Device Lot Number: 135928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 02/16/2010
• 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
• Patient Age: 80 YR
• Patient Sex: Male