MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE DEVICE

Model Number A219

Device Problems Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2021

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was explanted and replaced due to a sensing issue.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was explanted and replaced due to a sensing issue.No additional adverse patient effects were reported.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE DEVICE
• 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: 13262290
• MDR Text Key: 284174277
• Report Number: 2124215-2022-00474
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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: 12/11/2019
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 220007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• 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; Required Intervention