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

Model Number A219

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

This product is returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that during pre-implant interrogation this device began beeping tones and did not pass initial device check.The device had indicated elective replacement interval (eri) before implant.This device was returned for analysis.No adverse events.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, an evaluation of the device was performed.Review of the device memory confirmed that a elective replacement indicator (eri) was recorded.The device analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.It was determined that his device was stored in a low temperature setting that resulted in the eri indication.

Event Description

It was reported that during pre-implant interrogation this device began beeping tones and did not pass initial device check.The device had indicated elective replacement interval (eri) before implant.This device was returned for analysis.No adverse events.

• 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: 9208223
• MDR Text Key: 162883006
• Report Number: 2124215-2019-21469
• 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: 02/04/2020

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: 10/13/2019
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 217716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1