BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2525T MICRONY II, SR+, PKGD/STER

    MDR report key: 12005151 · Received June 15, 2021

    Report

    Report Number
    2017865-2021-20393
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    June 1, 2021
    Report Date
    November 8, 2021
    Manufacturer
    ABBOTT
    Product Code
    LWO
    UDI-DI
    05414734006224
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RECEIVED FROM THE FIELD WITH BATTERY AT END OF SERVICE (EOS) LEVEL. WHEN DEVICE IS AT EOS LEVEL THE MEASURED DATA MAY NOT BE ACCURATE. PROVIDED FIELD INFORMATION WAS ANALYZED AND NO ANOMALY WAS NOTED. RATE RESPONSIVE MODE WAS TURNED OFF WHEN DEVICE REACHED ERI, WHICH WAS AS EXPECTED. DEVICE WAS CUT OPEN AND FURTHER ELECTRICAL AND MECHANICAL ANALYSIS WERE PERFORMED, HIGH BATTERY IMPEDANCE WAS NOTED AS EXPECTED DUE TO BATTERY AT EOS. PROJECTED LONGEVITY ESTIMATION WAS PERFORMED, AND DEVICE HAD EXCEEDED PROJECTED LONGEVITY AND IS CONSIDERED NORMAL DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BATTERY IMPEDANCE ANOMALY AND INCREASED CAPTURE THRESHOLD ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901270 2525T MICRONY II, SR+, PKGD/STER IMPLANTABLE PACEMAKER PULSE GENERATOR LWO ABBOTT 2525T 4362752 05414734006224

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention