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

Model Number A219

Device Problem Migration (4003)

Patient Problems Bruise/Contusion (1754); Discomfort (2330); Implant Pain (4561)

Event Date 09/15/2022

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was revised due to migration, the device was not correctly anchored.The patient was received at the hospital with bruising on her breast-side area, pain, and discomfort.Subsequently, the s-icd was repositioned inter-muscular with a kangaroo pouch to hold it in place, and the procedure was completed.This s-icd remains in service and no additional 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: 15474384
• MDR Text Key: 300553769
• Report Number: 2124215-2022-37642
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2022
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 127631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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
• Patient Age: 56 YR
• Patient Sex: Female