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

Model Number 0672

Device Problems Defective Device (2588); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The return of the product was requested.If the product is returned, product investigation will be performed, and this complaint would be updated upon analysis completion.

Event Description

It was reported that this right ventricular (rv) lead was not successfully implanted due to unknown reason.Additional information received indicates that the lead was attempted due to coil was kinked after attempted to place in a patient with difficult anatomy.This lead was never in service.No adverse patient effects were reported.

Manufacturer Narrative

The return of the product was requested.If the product is returned, product investigation will be performed, and this complaint would be updated upon analysis completion.The unintended use error was selected based on the analysis finding of induced damage (bend in shock coils).The observed damage is not deemed to indicate a product defect or malfunction.

Event Description

It was reported that this right ventricular (rv) lead was not successfully implanted due to unknown reason.Additional information received indicates that the lead was attempted due to coil was kinked after attempted to place in a patient with difficult anatomy.This lead was never in service.No adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: 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: 18656443
• MDR Text Key: 334731849
• Report Number: 2124215-2024-06778
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592829
• UDI-Public: 00802526592829
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 235564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2023
• 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 Age: 60 YR
• Patient Sex: Male