MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE DEVICE

Model Number A209

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

Patient Problem Electric Shock (2554)

Event Date 01/05/2019

Event Type  malfunction  

Manufacturer Narrative

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 this subcutaneous implantable cardioverter defibrillator (s-icd) delivered inappropriate shock therapy while the patient was sleeping.Review of the stored episode noted that sensing appeared appropriate.Boston scientific technical services (ts) discussed troubleshooting options.Subsequently, the device exhibited t-wave oversensing resulting in delivery of an additional inappropriate shock.Programming changes were made for optimization.This product remains implanted and in service.No adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE DEVICE
• 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: 9922614
• MDR Text Key: 186361684
• Report Number: 2124215-2020-01652
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S043
• 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: 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: 01/18/2018
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 111960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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: 66 YR