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

Model Number A219

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Select Signal (1582); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

This device is still currently in service and not available for return.

Event Description

It was reported that the patient had previously experienced inappropriate shocks due to t-wave oversensing while exercising.The system was then programmed to primary sensing vector.Recently, the patient received two additional inappropriate shocks and the system was subsequently programmed to secondary vector.No additional adverse events.Kn.

• 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: 9921190
• MDR Text Key: 186323443
• Report Number: 2124215-2020-00620
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/26/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 244676
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• 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 Age: 29 YR