MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE S; Implantable Lead

Model Number	0138
Medical Device Problem Codes	Failure to Capture (1081); Failure to Read Input Signal (1581); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report will be updated when additional information is received.
Event or Problem Description
It was reported that the implanted device alerted due to low, out-of-range (oor) right ventricular (rv) pace impedance.The value had decreased from approximately 500 ohms to 221 ohms before decreasing further oor.It was also observed that the r-wave amplitude had decreased from 25 mv to 9 mv and the threshold test stopped running.The presenting electrogram demonstrated possible rv loss of capture.The shock channel electrogram (egm) was also negative and not like prior presenting egms.Technical services discussed the possibility of dislodgment or perforation and recommended evaluation of the patient in-clinic with x-ray imaging.No adverse patient effects were reported.The lead remains implanted and in service.

• Brand Name: ENDOTAK RELIANCE S
• 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 23427520
• Report Number: 2124215-2025-78185
• Device Sequence Number: 9863143
• Product Code: LWS
• UDI-Device Identifier: 00802526531118
• UDI-Public: (01)00802526531118(17)251103
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: 11/03/2025
• Device Model Number: 0138
• Device Catalogue Number: 0138
• Device Lot Number: 306779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 11/03/2023
• 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: 82 YR
• Patient Sex: Male