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

Model Number	0175
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a routine follow up, a red alert was displayed on the device that indicated high out of range shock impedances on the right ventricular (rv) lead were recorded.The health care professional (hcp) called technical services (ts) for further review.Ts reviewed the daily threshold and impedance measurements trend report findings with the hcp.At this time, no adverse patient effects were reported.This rv lead remains in service.
Event or Problem Description
It was reported that during a routine follow up, a red alert was displayed on the device that indicated high out of range shock impedances on the right ventricular (rv) lead were recorded.The health care professional (hcp) called technical services (ts) for further review.Ts reviewed the daily threshold and impedance measurements trend report findings with the hcp.At this time, no adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
This report is being submitted to correct the brand name (d1), pro code (product code) (d2b), model number, catalog number, expiration date, serial number, (root parent) gtin, (root parent) unique identifier (udi), unique identifier (udi) (d4) and implant date (d6a) in section d, suspect medical device.

• 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24241839
• Report Number: 2124215-2026-05917
• Device Sequence Number: 8970834
• Product Code: LWS
• UDI-Device Identifier: 00802526373732
• UDI-Public: (01)00802526373732(17)091022
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 03/25/2026

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: 10/22/2009
• Device Model Number: 0175
• Device Catalogue Number: 0175
• Device Lot Number: 1047182
• 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: 03/24/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 10/22/2007
• 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: 74 YR
• Patient Sex: Male