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

Model Number A219

Device Problems Premature Discharge of Battery (1057); 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 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Device is not available for return at this time.

Event Description

It was reported that this device displayed elective replace indicator (eri) after approximately three years.Analysis was performed indicating that this device is depleting prematurely.Subsequently, the device was explanted and replaced.No additional adverse patient effects were reported.

Event Description

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

Manufacturer Narrative

The returned s-icd was analyzed and a review of the device memory revealed no system errors and that the power consumption had been gradually increasing over the past year.The case was opened, the battery was removed, and an external power supply was connected to the device for further analysis.A higher than normal current drain was observed during testing.Comprehensive electrical testing isolated the high current condition to a degraded low voltage capacitor.The identified capacitor was removed and tested, independently quantifying the extent and behavior of the electrical leakage.Testing confirmed the compromised capacitor caused a high current drain condition.Based on the extensive testing performed, engineers concluded that the leakage characteristics of this compromised capacitor were caused by exposure to hydrogen gas within the pulse generator case.At this time.

• 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: 9576984
• MDR Text Key: 174553938
• Report Number: 2124215-2020-00352
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2018
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 203663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 127