BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 11574393 · Received March 26, 2021

    Report

    Report Number
    2017865-2021-12092
    Event Type
    Injury
    Date Received
    March 26, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 18, 2021
    Manufacturer
    ABBOTT
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF PREMATURE BATTERY DEPLETION WAS CONFIRMED. THE DEVICE WAS RECEIVED AT END OF SERVICE (EOS) VOLTAGE LEVEL. THE DEVICE IMAGE WAS REVIEWED AND REVEALED THE BATTERY VOLTAGE LEVEL DROPPED RAPIDLY. FURTHER ANALYSIS WAS PERFORMED BY CUTTING OPEN THE DEVICE TO MAKE DIRECT MEASUREMENTS ON THE INTERNAL CIRCUITRY, WHICH REVEALED HIGH CURRENT DRAIN FROM THE HYBRID CIRCUITRY. ADDITIONAL HYBRID TESTING CONCLUDED THAT A CAPACITOR ANOMALY WAS THE CAUSE OF HIGH CURRENT DRAIN AND PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO BE AT END OF SERVICE (EOS). ABBOTT TECHNICAL SUPPORT REVIEWED DEVICE SESSION RECORDS AND CONFIRMED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472954 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ABBOTT PM2272 P000084185 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention