BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTOS DR/CLS

    MDR report key: 1162262 · Received September 4, 2008

    Report

    Report Number
    1028232-2008-01064
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REP CALLED IN TO REPORT SOME UNUSUAL BEHAVIOR WITH A PROTOS DR/CLS. IT WAS IMPLANTED IN 2005 AND WHEN HE DID A BATTERY CHECK ON THE DEVICE, IT REPORTED THAT THE BATTERY STATUS WAS 'OK'. THE BATTERY VOLTAGE AT THE TIME OF THE CHECK WAS 2.19V AND THE BATTERY IMPEDANCE WAS 23 KOHMS. THE PATIENT IS PACEMAKER DEPENDANT AND THEY DECIDED TO CONDUCT A REPLACEMENT SINCE THE BATTERY VOLTAGE WAS SO LOW. HE REPORTED THAT WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE POCKET, THE PATIENT BECAME ASYSTOLIC IN THE VENTRICLES. THEY HAD VERIFIED THAT THE DEVICE WAS NOT PROGRAMMED TO UNIPOLAR SETTINGS. THE DEVICE WAS INTERROGATED AFTER THE IMPLANT AND THE BATTERY REPORTED "----". REP SAID THAT CHAD FERRELL STILL HAD THE DEVICE AND I CALLED HIM TO CONFIRM THAT HE WILL BE SENDING IT IN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOS DR/CLS PACEMAKER DXY BIOTRONIK GMBH AND CO 122300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization