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

Model Number 0672

Device Problems Failure to Capture (1081); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Perforation (2513); Unspecified Heart Problem (4454)

Event Date 09/02/2022

Event Type  Injury  

Manufacturer Narrative

At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that the patient implanted with this right ventricular (rv) lead experienced a perforation.The patient underwent surgical intervention to solve the issue.No additional adverse patient effects were reported.At this time, there is no indication of product return.

Manufacturer Narrative

At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that the patient implanted with this right ventricular (rv) lead experienced a perforation.The patient underwent surgical intervention to solve the issue.A new lead was implanted.No additional adverse patient effects were reported.This lead is not expected to be returned for analysis.Additional information was received which indicated the patient experienced palpitations and loss of capture (loc) at 5v as result of this perforation.A chest x ray was also performed.

Event Description

It was reported that the patient implanted with this right ventricular (rv) lead experienced a perforation.The patient underwent surgical intervention to solve the issue.A new lead was implanted.No additional adverse patient effects were reported.At this time, there is no indication of product return.This lead is not expected to be returned for analysis.

Manufacturer Narrative

At this time, no further information is available.Should additional information become available this report will be updated.

• 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: 16576672
• MDR Text Key: 311654692
• Report Number: 2124215-2023-13083
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2023
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 161434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 04/04/2023; 05/10/2023
• Supplement Dates FDA Received: 04/12/2023; 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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): Life Threatening; Hospitalization; Required Intervention