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

Model Number 0692

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Material Integrity Problem (2978)

Patient Problem Electric Shock (2554)

Event Date 11/27/2022

Event Type  Injury  

Event Description

It was reported that this patient reported to the hospital emergency room after receiving a shock.During the interrogation of the device, a code 1005 screen appeared on the programmer, indicative of a break in the energy or conductor system and revealed that this right ventricular (rv) lead exhibited high, out of range shock impedance (greater than 145 ohms).Increasing over the last 2 years.The patient was admitted to the hospital for monitoring.Lead integrity testing and device pocket maneuvers revealed noise.Subsequently this rv lead was surgically capped/abandoned (i.E., it remains implanted, but is no longer in service) and the device was explanted.Besides surgical intervention, no adverse patient effects were reported.This rv lead is not expected to be returned for analysis.

Manufacturer Narrative

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

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18017358
• MDR Text Key: 326674021
• Report Number: 2124215-2023-59886
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2023

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: 05/19/2018
• Device Model Number: 0692
• Device Catalogue Number: 0692
• Device Lot Number: 520027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization