BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTOS DR/CLS

    MDR report key: 3021799 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00747
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER WAS IMPLANTED FOR 68 MONTHS. UPON RECEIPT, THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE CLINICAL OBSERVATION WAS CONFIRMED THE DEVICE WAS NOT INTERROGATABLE. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY AS PROGRAMMED WITH A MAGNET FREQUENCY OF 80 PPM INDICATING THE BATTERY STATUS "ERI". THERE WAS NO INDICATION OF A DEVICE MALFUNCTION REGARDING THE ANTI-BRADYCARDIA THERAPY FUNCTIONALITY. NEXT, THE PACEMAKER WAS OPENED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES AND THE BATTERY WAS FOUND TO BE ALMOST DEPLETED. SUBSEQUENTLY, AT IN VIVO ENVIRONMENTAL CONDITION THE DEVICE WAS SUBJECTED TO A POWER ON RESET. AFTERWARDS THE DEVICE WAS PROVED TO BE FULLY FUNCTIONAL. PARTICULARLY AN INTERROGATION WAS PROPERLY FEASIBLE. THE CURRENT CONSUMPTION WAS AS EXPECTED. DURING ANALYSIS THE OBSERVED COMPROMISED INTERROGATION FUNCTIONALITY OF THE PACEMAKER WAS NOT REPRODUCIBLE. IN SUMMARY, DURING ANALYSIS THE CLINICAL OBSERVATION WAS CONFIRMED. DESPITE OF A THOROUGH ANALYSIS THE ROOT CAUSE FOR THE CLINICAL OBSERVATION WAS NOT DETERMINABLE. HOWEVER, IT IS BELIEVED THAT EXTERNAL INFLUENCES MIGHT HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION. IT IS THEREFORE VERY MUCH APPRECIATED TO RECEIVE THE INFORMATION WHETHER THE PATIENT UNDERWENT ANY THERAPIES.

    Description of Event or Problem · 1

    OUS MDR - DURING A 6 MONTH CHECK-UP, NO COMMUNICATION WAS POSSIBLE WITH THE DEVICE. SIX MONTHS PREVIOUS, THE BATTERY WAS AT 2.76 V/ 1 KOHM. 2Y, 11 MONTHS. WHEN PLACING THE PGH (WAND) ON DEVICE, DOO PACING, 81 PPM WAS NOTED. THIS DEVICE WAS PROGRAMMED TO VVI 45 PPM A FEW YEARS AGO AND ONLY FUNCTION AS A BACKUP WHEN NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124779 PROTOS DR/CLS PACEMAKER DXY BIOTRONIK SE & CO. KG 122300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization