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

Model Number	0181
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range shock impedances.The health care professional (hcp) called technical services (ts) for further review of the daily threshold and impedance measurements trend report.It was noted that the patient has a boston scientific right ventricular (rv) lead with a non-boston scientific subcutaneous coil implanted.Ts reviewed the daily threshold and impedance measurements trend report and determined an abrupt increase in shock impedances from 40 to 140 ohms.Ts discussed suspected cause and provided programming recommendations.At this time, no adverse patient effects were reported.This rv lead and non-boston scientific subcutaneous coil remain in service.
Additional Manufacturer Narrative
This product remains implanted and in-service.As such, physical analysis has not been conducted in our laboratory.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range shock impedances.The health care professional (hcp) called technical services (ts) for further review of the daily threshold and impedance measurements trend report.It was noted that the patient has a boston scientific right ventricular (rv) lead with a non-boston scientific subcutaneous coil implanted.Ts reviewed the daily threshold and impedance measurements trend report and determined an abrupt increase in shock impedances from 40 to 140 ohms.Ts discussed suspected cause and provided programming recommendations.At this time, no adverse patient effects were reported.This rv lead and non-boston scientific subcutaneous coil remain in service.Additional information was received that reported technical services (ts) was contacted for further review of the stored electrogram (egm) due to the high out of range shock impedances on the rv lead.Ts reviewed the egm and noted noise on the shock channel.Ts discussed possible causes and recommended for the lead to be further evaluated through isometrics and possibly xray imaging.No additional adverse patient effects were reported.This rv lead remains in service.

• 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; 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: 24228686
• Report Number: 2124215-2026-05662
• Device Sequence Number: 10188173
• Product Code: LWS
• UDI-Device Identifier: 00802526531156
• UDI-Public: (01)00802526531156(17)210315
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 03/15/2021
• Device Model Number: 0181
• Device Catalogue Number: 0181
• Device Lot Number: 338718
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 03/15/2019
• 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: 59 YR
• Patient Sex: Male