BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 10255420 · Received July 9, 2020

    Report

    Report Number
    2124215-2020-13487
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 15, 2020
    Report Date
    October 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE 3191 CAPTURES THE REPORTABLE EVENT OF SURGERY. ANALYSIS DETERMINED THAT THE FIRST RECORDED INSTANCE OF CODE 1003 OCCURRED ON (B)(6) 2020. AS SUCH THE EVENT DATE HAS BEEN MODIFIED FROM (B)(6) 2020 ACCORDINGLY. MKB THE RETURNED TELIGEN DEVICE 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. THE BEHAVIOR OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE'S 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE DEVICE RECORDED A CODE 1003, INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REVISION PROCEDURE WAS COMPLETED, AND A NEW DEVICE IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED, AND ANALYSIS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE DEVICE RECORDED A CODE 1003, INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REVISION PROCEDURE WAS COMPLETED, AND A NEW DEVICE IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719742 TELIGEN IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION F110 116191

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R