MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A209

Device Problems Pocket Stimulation (1463); Noise, Audible (3273)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 01/19/2021

Event Type  malfunction  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was deactivated due to fractured electrode.Despite being deactivated the device was emitting tones and patient reported feeling a low-level shock.Technical services (ts) reviewed the data and confirmed that the tones were due to the device re-detecting the high out-of-range impedance measurements due to the fractured electrode.The device is not providing any therapy so the only thing the patient might be feeling to explain the low-level shocks are the weekly impedance measurement testing.Ts continues to recommend replacing the fractured electrode to resolve the issue which is on hold due to covid.No adverse patient effects were reported.This device remains implanted but deactivated.New information received indicates that the device has since been explanted and returned for evaluation.

Manufacturer Narrative

Upon receipt, the device had no tones with magnet application and no telemetry.There was objective evidence that the associated electrode was fractured which led to the high impedance measurements.Visual inspection of the device noted an arc mark and an x-ray found that the plasma fuse was blown.Analysis concluded that when the device attempted to deliver a shock through the confirmed fractured lead internal components were damaged.

• Brand Name: EMBLEM S-ICD
• 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: 14538396
• MDR Text Key: 293286216
• Report Number: 2124215-2022-17415
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/13/2021
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 247213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1