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

Model Number 0673

Device Problem Failure to Capture (1081)

Patient Problem Perforation (2001)

Event Date 03/09/2024

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead exhibited loss of capture.The device was reprogrammed to try and allow left ventricular only pacing.Technical services (ts) was contacted, and ts discussed programming options.The physician suspected a micro perforation.Subsequently, the patient underwent a revision procedure and the rv lead was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that the right ventricular (rv) lead exhibited loss of capture.The device was reprogrammed to try and allow left ventricular only pacing.Technical services (ts) was contacted, and ts discussed programming options.The physician suspected a micro perforation.Subsequently, the patient underwent a revision procedure and the rv lead was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The related investigation determined that this lead was associated with a reported perforation with no conclusive evidence of a product performance issue; please refer to the description for more information regarding the specific circumstances of this event.

• 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: 18956252
• MDR Text Key: 338304168
• Report Number: 2124215-2024-17392
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592867
• UDI-Public: 00802526592867
• 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: 04/18/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 206467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female