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

Model Number A219

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 05/05/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort with the implanted system.The system was explanted.There were no additional adverse patient effects.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the device was examined.Visual inspection noted no damage.The device was then exposed to simulated heart load conditions, and the defibrillation functions were tested.The device operated appropriately, according to its performance specifications with no interruptions in therapy output or programmer communication at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Laboratory analysis did not identify any characteristics that would have caused or contributed to the reported clinical observations.

Event Description

This supplemental report is being filed to provide additional information regarding product analysis.It was reported that the patient experienced discomfort with the implanted system.The system was explanted.There were no additional adverse patient effects.

• 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: 16929520
• MDR Text Key: 315181664
• Report Number: 2124215-2023-23859
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 177793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• 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: 31 YR
• Patient Sex: Female