BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE DEVICE

    MDR report key: 8805045 · Received July 18, 2019

    Report

    Report Number
    2124215-2019-13851
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    May 29, 2019
    Report Date
    October 8, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P960040/S155
    Removal / Correction Number
    Z-0087-2015, Z0088-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEGRADATION AND RESULTANT PRODUCT PERFORMANCE ISSUE WITH THIS LOW-VOLTAGE CAPACITOR COMPONENT IS CAUSED BY THE PRESENCE OF EXCESS HYDROGEN GAS WITHIN THE PULSE GENERATOR CASE. INVESTIGATION DETERMINED THAT THE HYDROGEN WAS GENERATED BY A DIFFERENT COMPONENT (THE HIGH-VOLTAGE CAPACITORS). IN 2014, A NEW HIGH-VOLTAGE CAPACITOR DESIGN WAS IMPLEMENTED IN THE COGNIS, TELIGEN, INCEPTA, ENERGEN, PUNCTUA, AND SUBSEQUENT PRODUCT FAMILIES. THIS NEW DESIGN ELIMINATED THE GALVANIC EFFECT THAT CAN GENERATE EXCESS HYDROGEN IN THE SAME MANNER. THIS DEVICE WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS NEW HIGH-VOLTAGE CAPACITOR DESIGN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ANALYSIS OF THIS DEVICE WAS COMPLETED.

    Additional Manufacturer Narrative · 1

    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 A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO A PRODUCT PERFORMANCE 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 INCLUDED IN THE ADVISORY POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597238 IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION E110 129221

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R