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

Model Number D142

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 12/06/2019

Event Type  Injury  

Event Description

It was reported that a red alert was issued by the remote patient monitoring system indicating that the battery of this implantable cardioverter defibrillator (icd) was depleting prematurely.A boston scientific technical services (ts) reviewed the data and recommended emergent device replacement.No additional adverse patient effects were reported.The device was explanted and returned for analysis.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert (code 1003) was recorded, potentially indicative of early battery depletion.Analysis confirmed partial depletion, but the battery was still able to support full device function in the event that therapy was necessary.The early depletion was caused by electrical leakage of a low voltage capacitor in the presence of excess hydrogen gas within the pulse generator case.

Event Description

This report is being filed to submit the results of device analysis.

• Brand Name: INOGEN EL ICD DR
• 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: 9550654
• MDR Text Key: 173682101
• Report Number: 2124215-2019-27399
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534249
• UDI-Public: 00802526534249
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

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: 05/19/2017
• Device Model Number: D142
• Device Catalogue Number: D142
• Device Lot Number: 503126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 41 YR