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

Model Number A219

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Failure to Read Input Signal (1581); Data Problem (3196)

Patient Problem Electric Shock (2554)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited t wave oversensing resulting in untreated episode.Technical services (ts) noted a brief change in the qrs morphology that lead to short wide slow qrs complexes.The smart pass feature had been disabled on more than one occasion.Ts recommended a chest x ray.This s-icd remains in service.No adverse patient effects were reported.Additional information was received that this patient was brough in for a treadmill test to try to reproduce the t wave oversensing.Automatic setup was performed in which secondary and alternate vectors failed.A defibrillation threshold (dft) test was performed in primary vector and most beats were labeled as noise.The physician allowed the ventricular fibrillation (vf) to go for 16 seconds before externally rescuing.Dft was then performed in secondary with no issues with detection or conversion.It was noted that a system revision was already performed in the past.A stat request was made to have data from this device analyzed.Meanwhile, this patient was admitted to the hospital.It was suggested to give this patient muscle relaxants during the induction testing as the noise cause by involuntary muscle response may inhibit detection of vf during dft.The analysis request was cancelled, and this s-icd remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM MRI 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: 16819344
• MDR Text Key: 314048803
• Report Number: 2124215-2023-20164
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 247463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male