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

Model Number	0137
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited low out of range shock impedance measurements.In addition, oversensing of myopotential noise on the right ventricular (rv) channel was noted.Technical services (ts) was consulted, and it was recommended to replace the system.Subsequently, this crt-d system was explanted and replaced.Other than asystole for 2.5 seconds, pacing inhibition and the procedure, no additional adverse patient effects were reported.At this time, this rv lead has not been returned to boston scientific for further analysis.
Additional Manufacturer Narrative
This electrode was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual examination identified insulation damage in the electrode body in the region approximately 80 millimeters (mm) from the terminal pin, consistent with lead-on-can abrasion.Coils were intact with no damage found.Resistance testing found the electrode was not electrically continuous.Outer insulation showed surface abrasion approx.65mm from the terminal end.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited low out of range shock impedance measurements.In addition, oversensing of myopotential noise on the right ventricular (rv) channel was noted.Technical services (ts) was consulted, and it was recommended to replace the system.Subsequently, this crt-d system was explanted and replaced.Other than asystole for 2.5 seconds, pacing inhibition and the procedure, no additional adverse patient effects were reported.At this time, this rv lead was already returned to boston scientific.

• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21454732
• Report Number: 2124215-2025-11217
• Device Sequence Number: 4707920
• Product Code: LWS
• UDI-Device Identifier: 00802526531101
• UDI-Public: 00802526531101
• 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: 2024
• Device Explanted Year: 2025
• 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): 06/16/2025

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 Expiration Date: 10/12/2024
• Device Model Number: 0137
• Device Catalogue Number: 0137
• Device Lot Number: 301377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female