BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T PROMRI COATED

    MDR report key: 2914134 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03132
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 27, 2012
    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

    (B)(4) 2013 - THE IMPLANT, EXPLANT AND EVENT DATES WERE PROVIDED TO US. WE WERE ALSO INFORMED THIS DEVICE HAD BEEN RETURNED FOR ANALYSIS AFTER ITS RETURN, THE PACEMAKER UNDERWENT A VISUAL ANALYSIS. THE INSPECTION OF THE DEVICE SHOWED SCRATCHES ON THE INSCRIBED SIDE OF THE HOUSING AND TRACES OF SMOKE, WHICH MIGHT BE CONNECTED TO AN ELECTROCAUTERIZATION. NEXT, THE PACEMAKER UNDERWENT AN ELECTRICAL INCOMING GOODS INSPECTION. THE PACEMAKER WAS INTERROGATED, AND THE MEMORY CONTENT WAS ANALYZED. THE ANALYSIS OF THE MEMORY CONTENT SHOWED THAT THE DEVICE SWITCHED TO THE BATTERY STATUS ERI ON (B)(6) 2012. ANALYSIS SHOWED THAT THE BATTERY WAS NOT DISCHARGED. THE MEASUREMENT OF THE BATTERY VOLTAGE AND THE CHARGE COUNTERS WAS ABLE TO CONFIRM THIS. THE ERI STATUS WAS CAUSED BY A CORRUPTION OF THE PACEMAKER MEMORY CONTENT. THE PACEMAKER'S CAPABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL MATCHED THE PROGRAMMED VALUES IN ERI MODE, AND THE SIGNAL SENSING OF THE DEVICE WAS NORMAL. THE PACEMAKER SHOWED BEHAVIOR ACCORDING TO SPECIFICATIONS IN REGARD TO ITS THERAPY FUNCTIONS. THEN THE CORRUPTED MEMORY CONTENT WAS CORRECTED, AND THE ERI STATUS WAS RESET SUCCESSFULLY. SUBSEQUENTLY, THE PACEMAKER RESPONDED AS EXPECTED. A REPEAT OF THE SWITCH INTO ERI STATUS COULD NOT BE OBSERVED. IN SUMMARY, IT CAN BE SAID THAT THE CLINICAL OBSERVATION COULD BE CONFIRMED. THE CAUSE FOR THE CLINICAL OBSERVATION WAS A CORRUPTED MEMORY CONTENT. AFTER THE CORRECTION OF THE CORRUPTED MEMORY CONTENT, THE BEHAVIOR OF THE PACEMAKER CONFORMED TO SPECIFICATIONS. IN CONCLUSION, IT CANNOT BE RULED OUT THAT EXTERNAL INFLUENCES, SUCH AS STRONG ELECTROMAGNETIC FIELDS, HAVE CONTRIBUTED TO THE ACTIVATION OF THE ERI STATUS. THERE WAS NO MATERIAL DEFECT OR MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE DEVICE INDICATED ERI. THE PT UNDERWENT A LUNG SURGERY RECENTLY. THIS IS ALL OF THE PROVIDED INFO AT THIS TIME. THERE WAS NO INDICATION OF EXPLANT AND NO IMPLANT OR EVENT DATE WAS PROVIDED. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE DEVICE INDICATED ERI. THE PATIENT UNDERWENT A LUNG SURGERY RECENTLY. THIS IS ALL OF THE PROVIDED INFORMATION AT THIS TIME. THERE WAS NO INDICATION OF EXPLANT AND NO IMPLANT OR EVENT DATE WAS PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIA DR-T PROMRI COATED PACEMAKER DXY BIOTRONIK SE & CO. KG 372032

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization