MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number E110

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

It was reported that prior to a scheduled replacement, this implantable cardioverter defibrillator (icd) was unable to be interrogated.It was noted that the device had declared end of life (eol) battery status after nearly 13 years in implanted, and that the patient had not presented for scheduled follow-ups in several years.As such the interrogation difficulties were believed to a result of a depleted battery.This device was successfully replaced as planned.No adverse patient effects were reported.This device was subsequently returned and analyzed.

Manufacturer Narrative

This icd was analyzed.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 battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to this anomaly.Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion.This particular device was not included in the advisory population.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 18368148
• MDR Text Key: 331109567
• Report Number: 2124215-2023-72702
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/07/2011
• Device Model Number: E110
• Device Catalogue Number: E110
• Device Lot Number: 144642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2010
• 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: 78 YR
• Patient Sex: Male