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

Model Number A219

Device Problems No Audible Alarm (1019); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2023

Event Type  malfunction  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was not responsive to interrogations after using numerous programmers, and to magnet application.Beeping tones were not emitted when expected.It was suspected that this issue was caused as the patient had a magnetic resonance imaging (mri) and the mri mode of the s-icd was not turned on.Reportedly, the device never regained any functionality.The patient has other more critical care needs that are being addressed, and a replacement procedure while occur until further notice.This s-icd remains in service and no adverse patient effects were reported.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)
• 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: 16353402
• MDR Text Key: 309293894
• Report Number: 2124215-2023-05956
• 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: Other
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2022
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 129052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female