MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number	0636
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Convert Rhythm (1540); Under-Sensing (1661)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Electric Shock (2554)
Date of Event	09/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that physiologic noise coming for this patient with the cardiac resynchronization therapy defibrillator (crt-d) induced the patient into a ventricular tachycardia episode that evolved into ventricular fibrillation.Furthermore, undersensing was observed on this right ventricular lead, even though, the device was still able to deliver anti-tachycardia pacing (atp) therapy on the patient, however they were not successful.Eventually the episode ended due to external shock provided to the patient.Further evaluation of the patient was discussed.This lead remains in service.No further adverse patient effects were reported.
Event or Problem Description
It was reported that physiologic noise coming for this patient with the cardiac resynchronization therapy defibrillator (crt-d) induced the patient into a ventricular tachycardia episode that evolved into ventricular fibrillation.Furthermore, undersensing was observed on this right ventricular lead, even though, the device was still able to deliver anti-tachycardia pacing (atp) therapy on the patient, however they were not successful.Eventually the episode ended due to external shock provided to the patient.Further evaluation of the patient was discussed.This lead remains in service.No further adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• 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: 16744164
• Report Number: 2124215-2023-17712
• Device Sequence Number: 15113818
• Product Code: LWS
• UDI-Device Identifier: 00802526496868
• UDI-Public: 00802526496868
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/16/2023

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: 03/14/2023
• Device Model Number: 0636
• Device Catalogue Number: 0636
• Device Lot Number: 506895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2021
• 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
• Patient Age: 84 YR
• Patient Sex: Male