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

Model Number	0138
Medical Device Problem Codes	Signal Artifact/Noise (1036); Mechanical Problem (1384); Over-Sensing (1438); Device Contamination with Body Fluid (2317); Defective Device (2588); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this right ventricular (rv) lead was scheduled for lead revision due to oversensed noise from contact with the left bundle branch (lbb) lead.The patient's extreme tricuspid valve regurgitation required multiple fixation attempts.At one point, tissue became entrapped in the helix mechanism and required more than 30 turns to get the helix to retract.Subsequently both the rv and lbb leads were explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.Correction to h6: device code a0203/defective device was removed.
Event or Problem Description
It was reported that this right ventricular (rv) lead was scheduled for lead revision due to oversensed noise from contact with the left bundle branch (lbb) lead.The patient's extreme tricuspid valve regurgitation required multiple fixation attempts.At one point, tissue became entrapped in the helix mechanism and required more than 30 turns to get the helix to retract.Subsequently both the rv and lbb leads were explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection of the lead found that the helix mechanism was extended and dried blood was noted in the helix housing.A laboratory technician tested the helix mechanism and found it was nonfunctional, confirming the clinical observation.Based upon the clinical observations and the laboratory findings, we believe that body fluid inside the helix housing may have contributed to the irregularity in helix function.Correction to h6: device code a0203/defective device was removed.
Event or Problem Description
It was reported that this right ventricular (rv) lead was scheduled for lead revision due to oversensed noise from contact with the left bundle branch (lbb) lead.The patient's extreme tricuspid valve regurgitation required multiple fixation attempts.At one point, tissue became entrapped in the helix mechanism and required more than 30 turns to get the helix to retract.Subsequently both the rv and lbb leads were explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE S
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 22798366
• Report Number: 2124215-2025-56615
• Device Sequence Number: 8512326
• Product Code: LWS
• UDI-Device Identifier: 00802526531118
• UDI-Public: (01)00802526531118(17)270124
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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: 0138
• Device Catalogue Number: 0138
• Device Lot Number: 308307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 11/09/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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: 66 YR
• Patient Sex: Female