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

Model Number	0181
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Data Problem (3196)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that a cardiac resynchronization therapy defibrillator (crt-d) system with a right ventricular (rv) lead exhibited noise oversensing on the ventricular channel, resulting in pacing inhibition greater than two seconds during a stored ventricular episode.The patient was reported to be pacing dependent.Technical services (ts) reviewed the shock impedance history and indicated that there were no signs of a gradual rise suggestive of a progressive lead integrity issue; however, some gaps in the data were noted.Ts reviewed the stored episode and indicated that the noisy signals appeared more consistent with diaphragmatic activity rather than a lead integrity issue.Review of rate counters showed numerous sensed events at rates greater than 250 beats per minute (bpm) despite a limited number of stored ventricular episodes, suggesting that oversensing may be occurring more than the total number of stored episodes indicates.The field representative reported that programming optimization was performed and that similar noise could be reproduced during deep breathing.No additional adverse patient effects were reported.This rv lead remains in service.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system with this right ventricular (rv) lead exhibited noise oversensing on the ventricular channel, resulting in pacing inhibition greater than two seconds during a stored ventricular episode.The patient was reported to be pacing dependent.Technical services (ts) reviewed the shock impedance history and indicated that there were no signs of a gradual rise suggestive of a progressive lead integrity issue; however, some gaps in the data were noted.Ts reviewed the stored episode and indicated that the noisy signals appeared more consistent with diaphragmatic activity rather than a lead integrity issue.Review of rate counters showed numerous sensed events at rates greater than 250 beats per minute (bpm) despite a limited number of stored ventricular episodes, suggesting that oversensing may be occurring more than the total number of stored episodes indicates.The field representative reported that programming optimization was performed and that similar noise could be reproduced during deep breathing.No additional adverse patient effects were reported.This rv lead remains in service.Additional information confirmed that the identified root cause was diaphragmatic oversensing, and the issue was attributed to the lead only.Programming optimization was performed as an initial corrective action, with the option of is-1 lead addition if the patient elects to proceed.The current plan is to continue monitoring the patient.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: ENDOTAK RELIANCE SG
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24708887
• Report Number: 2124215-2026-16858
• Device Sequence Number: 10176233
• Product Code: LWS
• UDI-Device Identifier: 00802526531156
• UDI-Public: (01)00802526531156(17)181116
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2026

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: 11/16/2018
• Device Model Number: 0181
• Device Catalogue Number: 0181
• Device Lot Number: 333773
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 07/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/17/2026; 07/02/2026
• Date Device Manufactured: 11/16/2016
• 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: 65 YR
• Patient Sex: Male