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

Model Number A219

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

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

Event Date 12/21/2019

Event Type  malfunction  

Manufacturer Narrative

The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) recorded a battery depletion message.Analysis of device memory confirmed the presence of a battery depletion message due to excessive magnet applications.It was reported that the patient underwent a surgical procedure on the date of the magnet applications.Boston scientific technical services (ts) discussed confirming removal of the magnet and performing a follow up device check on a future date to confirm if the battery status is recovering.Available information indicates this product remains implanted and in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited a battery depletion error; however, the error was not representative of actual fast battery depletion and was unintended.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that a subsequent interrogation of this device noted the battery status had recovered to 96 percent and the battery depletion message had cleared.This product remains implanted and in service.

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 a subsequent interrogation of this device noted the battery status had recovered to 96 percent and the battery depletion message had cleared.This product remains implanted and in service.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9592274
• MDR Text Key: 175098745
• Report Number: 2124215-2020-00647
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

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: 06/28/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 249767
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 01/17/2020; 02/11/2020
• Supplement Dates FDA Received: 04/06/2020; 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR