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

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 12/19/2019

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) recorded a battery depletion message resulting in an alert in the remote home monitoring system.Analysis of device memory confirmed the presence of a battery depletion message due to excessive magnet applications.It was reported that the patient underwent several unrelated surgical procedures around the time the message was recorded.Analysis of device memory noted that the battery status showed signs of improvement in the absence of a magnet and boston scientific technical services (ts) felt the battery status should continue to recover.Available information indicates this device remains implanted and in service.No adverse patient effects were reported.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) recorded a battery depletion message resulting in an alert in the remote home monitoring system.Analysis of device memory confirmed the presence of a battery depletion message due to excessive magnet applications.It was reported that the patient underwent several unrelated surgical procedures around the time the message was recorded.Analysis of device memory noted that the battery status showed signs of improvement in the absence of a magnet and boston scientific technical services (ts) felt the battery status should continue to recover.Available information indicates this device 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.

• 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
• MDR Report Key: 9596777
• MDR Text Key: 175269870
• Report Number: 2124215-2020-00806
• 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
• Report Date: 04/10/2020

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: 08/08/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 251729
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR