BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 10368531 · Received August 5, 2020

    Report

    Report Number
    2124215-2020-16586
    Event Type
    Injury
    Date Received
    August 5, 2020
    Date of Event
    June 9, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE 3191 CAPTURES THE REPORTABLE EVENT OF SURGERY. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME. 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,BUT STILL SUPPORTED FULL DEVICE FUNCTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED AND DEVICE REPLACEMENT WAS RECOMMENDED. THE PATIENT WAS RELEASED TO HOE PENDING A REPLACEMENT PROCEDURE. THE FIELD REPRESENTATIVE CONFIRMED THE DEVICE WAS EXPLANTED AND REPLACED ALMOST THREE WEEKS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS RETURNED FOR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED AND DEVICE REPLACEMENT WAS RECOMMENDED. THE PATIENT WAS RELEASED TO HOE PENDING A REPLACEMENT PROCEDURE. THE FIELD REPRESENTATIVE CONFIRMED THE DEVICE WAS EXPLANTED AND REPLACED ALMOST THREE WEEKS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834176 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LWP BOSTON SCIENTIFIC CORPORATION F103 115505

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R