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

Model Number 0672

Device Problems Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problem Cardiac Perforation (2513)

Event Date 03/23/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this right ventricular (rv) lead exhibited high pacing threshold measurements.The physician ordered for chest x-ray and discovered that the lead had an odd position and pericardial perforation was suspected.This rv lead was surgically repositioned and remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.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 malfunction; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this right ventricular (rv) lead exhibited high pacing threshold measurements.The physician ordered for chest x-ray and discovered that the lead had an odd position and pericardial perforation was suspected.This rv lead was surgically repositioned and remains in service.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: 16709317
• MDR Text Key: 312977669
• Report Number: 2124215-2023-16642
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 195737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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; Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male