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

Model Number 0673

Device Problem Failure to Capture (1081)

Patient Problem Cardiac Perforation (2513)

Event Date 04/06/2024

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited intermittent to no capture on the presenting electrogram (egm) and stored rythmiq events.This lead was explanted due to perforation and replaced with a new rv lead.No additional adverse patient effects were reported.As of today, this product has not been returned for additional analysis.

Event Description

It was reported that this right ventricular (rv) lead exhibited intermittent to no capture on the presenting electrogram (egm) and stored rythmiq events.This lead was explanted due to perforation and replaced with a new rv lead.No additional adverse patient effects were reported.As of today, this product has not been returned for additional analysis.

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: 19201907
• MDR Text Key: 341269664
• Report Number: 2124215-2024-25710
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592867
• UDI-Public: 00802526592867
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2022
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 133944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male