MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0672

Device Problems Fracture (1260); Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

Event Description

It was reported that the patient with this right ventricular (rv) lead had an infection.Moreover, contamination in the lead electrode end, terminal end, and insulation was noted.In addition, the lead incurred conductor fracture.The lead was explanted.No additional adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: 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: 12735705
• MDR Text Key: 279517729
• Report Number: 2124215-2021-33302
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592829
• UDI-Public: 00802526592829
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/07/2023
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 160118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR