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

Model Number	0286
Medical Device Problem Codes	High impedance (1291); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a clinic visit, the health care professional (hcp) called technical services (ts) for further review of this cardiac resynchronization therapy defibrillator (crt-d) to confirm device operation.It was noted that the device had recorded a supraventricular tachycardia (svt) episode.Upon review, the presenting electrogram (egm) showed the device had inappropriately delivered eight bursts of anti-tachycardia pacing (atp) and six shocks in attempt to convert the rhythm.Therapy was exhausted.Further review of the shocks showed that a code 1005 which indicated an open circuit condition was triggered due to high out of range shock impedances had been recorded on the right ventricular (rv) lead during shock delivery.Ts reviewed the daily impedance trend report and observed that the rv lead shock impedances appeared to have been gradually increasing over time to be greater than 125 ohms.Ts discussed possible causes with the hcp, recommending for the rv lead to be replaced.At this time, the rv lead remains in service.No additional adverse effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific and physical analysis could not be conducted.Investigation of the available information/data determined that the observed gradual rise in lvsi measurements was likely associated with calcification, as there was no conclusive evidence of compromised physical or electrical integrity of the lead.This condition may develop over time and can be reflected in a gradual and sustained increase in shock impedance measurements.Boston scientific issued a field safety notice to physicians in july 2025 regarding the potential for reliance defibrillation leads with expanded polytetrafluoroethylene (eptfe) coating to exhibit a pattern of gradually increasing lvsi measurements due to calcification, which may result in elevated high voltage shock impedance (hvsi) measurements and reduced shock efficacy.
Event or Problem Description
It was reported that during a clinic visit, the health care professional (hcp) called technical services (ts) for further review of this cardiac resynchronization therapy defibrillator (crt-d) to confirm device operation.It was noted that the device had recorded a supraventricular tachycardia (svt) episode.Upon review, the presenting electrogram (egm) showed the device had inappropriately delivered eight bursts of anti-tachycardia pacing (atp) and six shocks in attempt to convert the rhythm.Therapy was exhausted.Further review of the shocks showed that a code 1005 which indicated an open circuit condition was triggered due to high out of range shock impedances had been recorded on the right ventricular (rv) lead during shock delivery.Ts reviewed the daily impedance trend report and observed that the rv lead shock impedances appeared to have been gradually increasing over time to be greater than 125 ohms.Ts discussed possible causes with the hcp, recommending for the rv lead to be replaced.At this time, the rv lead remains in service.No additional adverse effects were reported.

• 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: 22772977
• Report Number: 2124215-2025-55786
• Device Sequence Number: 13096793
• Product Code: NVY
• UDI-Device Identifier: 00802526431418
• UDI-Public: (01)00802526431418(17)161009
• 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: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 10/09/2016
• Device Model Number: 0286
• Device Catalogue Number: 0286
• Device Lot Number: 319626
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 11/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 10/09/2014
• 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: 61 YR
• Patient Sex: Male