MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0275
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
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 the patient implanted with this implantable cardioverter defibrillator (icd) and right ventricular (rv) defibrillation lead received three shocks.The first shock was given for a rhythm that the physician deemed non life-threatening.The second shock made the situation worse, and the third shock converted.The physician stated that the wire was in the wrong place.The device was programmed off, the patient was given a life vest, and lead revision was planned for january 2025.It was noted that the patient was part of a study with additional software.Technical services (ts) was unaware of the what trial the patient was in, and recommended that the physician follow up with the clinical trial about the additional software.This rv lead remains in service at this time.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) and right ventricular (rv) defibrillation lead received three shocks.The first shock was given for a rhythm that the physician deemed non-life-threatening.The second shock made the situation worse, and the third shock converted.The physician stated that the wire was in the wrong place.The device was programmed off, the patient was given a life vest, and lead revision was planned for (b)(6) 2025.It was noted that the patient was part of a study with additional software.Technical services (ts) was unaware of the what trial the patient was in and recommended that the physician follow up with the clinical trial about the additional software.This rv lead remains in service at this time.No additional adverse patient effects were reported.Additional information received reported that this rv lead was explanted and replaced.No additional adverse patient effects were reported.Product return was requested.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding product return status.At this time, no further information is available.Should additional information become available this report will be updated.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 20916769
• Report Number: 2124215-2024-78735
• Device Sequence Number: 20097719
• Product Code: NVY
• UDI-Device Identifier: 00802526531224
• UDI-Public: 00802526531224
• 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: 2020
• 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
• Report Date (Section B): 02/12/2025

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: 11/09/2020
• Device Model Number: 0275
• Device Catalogue Number: 0275
• Device Lot Number: 419957
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/12/2025
• Date Device Manufactured: 11/09/2018
• 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; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male