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 Problems Syncope (1610); Patient Problem/Medical Problem (2688)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

The device remains implanted.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient with this subcutaneous implantable cardioverter defibrillator (s-icd) experienced a syncopal event four days post implant while at a dialysis appointment.The patient was found by a healthcare provider after the device provided therapy.The root cause of the syncope was not determined.No additional 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8504957
• MDR Text Key: 141628228
• Report Number: 2124215-2019-06248
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2019

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 Expiration Date: 08/17/2020
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 233565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 48 YR