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

Model Number 0693

Device Problems Fracture (1260); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Defective Device (2588)

Patient Problem Shock (2072)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

At this time the product has not been returned; therefore there is no way to determine how the lead may or may have not effected the clinics observation.If the product is returned, and supplemental report will be submitted.

Event Description

It was reported during a routine device change out procedure the physician reported that this right ventricular (rv) lead had a lead insulation defect, conductor fracture.Prior to explant it was reported that this rv lead exhibited high out of range impedances, noise and an inappropriate shock.Attempts to identify the high out of range impedance measurements have been unsuccessful at this time.The rv lead was explanted, and a new lead implanted.The rv lead is expected to be returned for analysis.Besides surgical intervention, no adverse 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16519525
• MDR Text Key: 311035791
• Report Number: 2124215-2023-11230
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2019
• Device Model Number: 0693
• Device Catalogue Number: 0693
• Device Lot Number: 519898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization