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 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

No further information concerning this report is currently available.This investigation will be updated should further information be provided.

Event Description

It was reported that during subcutaneous implantable cardioverter defibrillator (s-icd) implant procedure the device displayed a message indicating that it should not be implanted.The device was not implanted at this time.No adverse events.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, it was noted that the device was returned in the original sterile packaging.An evaluation of the device was performed.The device was turned on with no red code that was noted in the field.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Review of the device memory noted that, was recorded and that the device recorded a lower temperature readings.If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result.This appears to be the case with this device.

Event Description

This supplemental report is being filled to include device analysis information.

• 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: 9593519
• MDR Text Key: 175195544
• Report Number: 2124215-2019-27457
• 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: 08/05/2020

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: 05/28/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 248218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1