MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D010

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/06/2019

Event Type  Injury  

Manufacturer Narrative

Following completion of laboratory analysis, this event will be further updated.

Event Description

It was reported that this device exhibited a fault code indicative of an extended charge time and thus then triggered a battery end of life (eol).The field representative confirmed no mri exposure as the potential root cause thus, resulting in the immediate replacement recommendation.The patient was hospitalized for the replacement procedure.The replacement was reported without complications and the explanted device later returned for analysis.

Manufacturer Narrative

A thorough evaluation of the device was performed upon receipt at our post market quality assurance laboratory.Visual inspection of the device noted no anomalies.Review of device memory indicated that a charge timeout alert of greater than 45 seconds, had been recorded.The device case was opened, and visual inspection noted that one of the high voltage (hv) capacitors was slightly swollen.The hv capacitor was analyzed, and it was concluded that the hv capacitor experienced internal arcing caused by a low resistance pathway between anode and cathode plates within the capacitor.This capacitor issue impacted the device's ability to provide shock therapy because the hv capacitors could not be fully charged, but brady pacing, telemetry, and other device functionality remained available.

Event Description

It was reported that this device exhibited a fault code indicative of an extended charge time and thus then triggered a battery end of life (eol).The field representative confirmed no mri exposure as the potential root cause thus, resulting in the immediate replacement recommendation.The patient was hospitalized for the replacement procedure.The replacement was reported without complications and the explanted device later returned for analysis.

• Brand Name: INOGEN MINI ICD VR
• 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: 9576789
• MDR Text Key: 174559133
• Report Number: 2124215-2019-27940
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526533785
• UDI-Public: 00802526533785
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S306
• 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: 05/28/2017
• Device Model Number: D010
• Device Catalogue Number: D010
• Device Lot Number: 207530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 04/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening