MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN ICD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number E140

Device Problems No Audible Alarm (1019); Telemetry Discrepancy (1629)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The returned implantable cardioverter defibrillator (icd) was analyzed and a review of the device memory confirmed that a low voltage alert, code 1003, was recorded.The battery voltage was lower than expected.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high-current condition associated with a compromised low-voltage capacitor connected to the device's battery.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Investigation has determined that the low voltage capacitors can become compromised due to the presence of excess hydrogen gas within the device case.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.Boston scientific has issued a field safety notice regarding a subset of cognis/teligen devices that has an elevated potential of exhibiting this behavior.This particular device was not included in the low voltage capacitor advisory population however, this capacitor behavior can still occur in non-advisory devices.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator expired.There was no allegation that the device caused or contributed to the death, but a request was made for analysis of device data to help understand the cause of death.An attempt to interrogate the device approximately two months after the patient passed was unsuccessful and no tones were present upon magnet application.The device underwent analysis.

• Brand Name: ENERGEN ICD
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11227766
• MDR Text Key: 241236528
• Report Number: 2124215-2020-28949
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480713
• UDI-Public: 00802526480713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/29/2013
• Device Model Number: E140
• Device Catalogue Number: E140
• Device Lot Number: 100311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR