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

Model Number	0276
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead was explanted and replaced due to loss of capture (loc).No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and lead return status.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead was explanted and replaced due to loss of capture (loc).No additional adverse patient effects were reported.Additional information received reported that right ventricular (rv) defibrillation lead loss of capture (loc) was confirmed with threshold testing and x-rays, prior to lead revision.No additional adverse patient effects were reported.This rv lead is expected to be returned by the hospital.
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead was explanted and replaced due to loss of capture (loc).No additional adverse patient effects were reported.Additional information received reported that right ventricular (rv) defibrillation lead loss of capture (loc) was confirmed with threshold testing and x-rays, prior to lead revision.No additional adverse patient effects were reported.This rv lead is expected to be returned by the hospital.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ENDOTAK RELIANCE
• 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: 18062256
• Report Number: 2124215-2023-61561
• Device Sequence Number: 7527867
• Product Code: NVY
• UDI-Device Identifier: 00802526531231
• UDI-Public: 00802526531231
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2024

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: 05/28/2024
• Device Model Number: 0276
• Device Catalogue Number: 0276
• Device Lot Number: 426727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/25/2023; 12/14/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/03/2023; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male