MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE S; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	0137
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Failure to Read Input Signal (1581); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) exhibited low intrinsic amplitude and an increase in rv lead impedance within normal limits.The device, implanted a few months prior, showed stable r-wave measurements initially, followed by a significant decrease in amplitude and a rise in impedance.Review of device data also noted noise on the shock electrogram and oversensing on the rv channel.The health care professional (hcp) suspected possible lead dislodgement, and troubleshooting steps including imaging and further evaluation of lead position were recommended.This rv lead remains in service.
Event or Problem Description
It was reported that this right ventricular (rv) exhibited low intrinsic amplitude and an increase in rv lead impedance within normal limits.The device, implanted a few months prior, showed stable r-wave measurements initially, followed by a significant decrease in amplitude and a rise in impedance.Review of device data also noted noise on the shock electrogram and oversensing on the rv channel.The health care professional (hcp) suspected possible lead dislodgement, and troubleshooting steps including imaging and further evaluation of lead position were recommended.This rv lead remains in service.Additional information was received that this rv lead was successfully explanted and replaced.No additional adverse patient effects were reported outside the revision procedure.Additional information was received that this lead exhibited a dislodgment.No adverse patient effects were reported.
Additional Manufacturer Narrative
Follow up report 2 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.
Event or Problem Description
It was reported that this right ventricular (rv) exhibited low intrinsic amplitude and an increase in rv lead impedance within normal limits.The device, implanted a few months prior, showed stable r-wave measurements initially, followed by a significant decrease in amplitude and a rise in impedance.Review of device data also noted noise on the shock electrogram and oversensing on the rv channel.The health care professional (hcp) suspected possible lead dislodgement, and troubleshooting steps including imaging and further evaluation of lead position were recommended.This rv lead remains in service.Additional information was received that this rv lead was successfully explanted and replaced.No additional adverse patient effects were reported outside the revision procedure.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.

• Brand Name: ENDOTAK RELIANCE S
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 24678395
• Report Number: 2124215-2026-15959
• Device Sequence Number: 12032031
• Product Code: LWS
• UDI-Device Identifier: 00802526531101
• UDI-Public: (01)00802526531101(17)270625
• 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: 2025
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 04/10/2026

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 Model Number: 0137
• Device Catalogue Number: 0137
• Device Lot Number: 301941
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/26/2026; 04/06/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/11/2026
• Date Device Manufactured: 06/25/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female