BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICS 3000 OM-3 US

    MDR report key: 3232146 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01983
    Event Type
    Death
    Date Received
    July 17, 2013
    Date of Event
    June 13, 2013
    Report Date
    July 4, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROGRAMMER UNDERWENT A FUNCTIONAL AND A VISUAL/MECHANICAL CHECK. THE FOLLOWING DESCRIBES THE RESULTS OF THE FUNCTIONAL CHECK. THE DEVICE UNDERWENT A FUNCTIONAL CHECK. IT WAS DIVIDED INTO THE FOLLOWING ANALYSIS STEPS: STARTUP OF THE DEVICE, CHECK OF THE USER PROGRAM AND ITS OPERATION, CHECK OF THE DISPLAY ELEMENTS, INTERFACES, AND THE PERIPHERY (MONITOR, PRINTER, PROGRAMMING WAND). TEST OF PACING AND SENSING. THE DEVICE WAS ACTIVATED, AND THE OPERATING SYSTEM AND THE USER PROGRAM WERE STARTED. THE DEVICE COULD BE OPERATED WITHOUT RESTRICTIONS VIA THE TOUCH-SENSITIVE SCREEN. IMPLANTS COULD BE INTERROGATED SUCCESSFULLY AND RELIABLY. DATA COULD BE TRANSMITTED FROM THE IMPLANT TO THE PROGRAMMER AND VICE VERSA WITHOUT ERRORS. WHEN THE PROGRAMMING WAND WAS ELECTRICALLY SEPARATED FROM THE CONTROL UNIT, AN ERROR MESSAGE APPEARED AS EXPECTED. THE FUNCTIONING OF PACING AND SENSING WAS CHECKED WITH THE HELP OF A HEART SIMULATOR. THE DEVICE DETECTED AS EXPECTED AND PACED. THERE WERE NO PACING LOSSES, NOT EVEN DURING THE LONG-TERM TEST. THE DEVICE THEN UNDERWENT A MECHANICAL PROVOCATION TEST. WHEN APPLYING STRONG EXTERNAL MECHANICAL STRESS ON INDIVIDUAL DEVICE PARTS, A BRIEF INTERMITTENT CONTACT INTERRUPTION BETWEEN CONTROL AND PACING UNIT COULD BE OBSERVED. DURING THE ANALYSIS, A DEFORMATION OF THE HOUSING, WHICH WAS PROBABLY CAUSED BY EXTERNAL MECHANICAL STRESS, WAS NOTED. IN ADDITION, A NOTICEABLE AMOUNT OF DIRT WAS FOUND IN THE CONTACTING AREA. AFTER CLEANING THE CONTACTING AREA, FINAL FACTORY TESTING WAS PERFORMED, WHICH WAS PASSED BY THE DEVICE. THE REVIEW OF THE PRODUCTION DOCUMENTS REGARDING THE PROGRAMMER DID NOT SHOW ANY ANOMALIES. IN SUMMARY, THERE WAS NO INDICATION OF A MATERIAL DEFECT OR MANUFACTURING ERROR. BOTH THE DIRT AT THE CONTACTS AND THE HOUSING DEFORMATION COULD HAVE POSSIBLY CONTRIBUTED TO THE BEHAVIOR OF THE DEVICE OBSERVED AFTER THE OPERATION.

    Description of Event or Problem · 1

    OUS MDR - ON (B)(6) 2013, THE NEW IMPLANTATION OF A CARDIAC PACEMAKER WAS PLANNED. THE (B)(6) FEMALE PATIENT HAD AN INDICATION OF A 3RD DEGREE AV BLOCK AND RECURRING SYNCOPE'S. DURING IMPLANTATION, COMPLICATIONS AROSE, WHICH NECESSITATED INTUBATION AND CALLING FOR AN EMERGENCY TEAM. DURING THE RESUSCITATION ATTEMPTS, A LEAD WAS PLACED FOR THE PURPOSE OF STIMULATION. SINCE THE AVAILABLE EXTERNAL DEFIBRILLATOR HAD NO PACING FUNCTION AND SINCE NO OTHER EXTERNAL STIMULATOR WAS AVAILABLE, PACING WAS TEMPORARILY PERFORMED WITH THIS PROGRAMMER VIA THE IMPLANT MODULE. THIS STIMULATION WAS SUCCESSFUL. NEVERTHELESS, THE PATIENT REMAINED IN AN UNSTABLE STATE WITH VF EPISODES AND THE NECESSITY OF REPEATED EXTERNAL DEFIBRILLATION. A SECOND LEAD WAS IMPLANTED, WHICH WAS CONNECTED TO THIS PROGRAMMER. STILL THE STATE OF THE PATIENT REMAINED CRITICAL, ACCOMPANIED BY TACHYCARDIA AND A DROP IN BLOOD PRESSURE. DUE TO A MEDICAL WILL BY THE PATIENT, SHE WAS NOT CONNECTED TO A VENTILATOR. THE PATIENT DIED. IT WAS REPORTED THAT TOWARDS THE END OF THE OPERATION, A BRIEF PACING LOSS OF THE PROGRAMMER WAS OBSERVED AFTER THE DEVICE HAD BEEN MOVED AROUND ON THE TABLE. THIS OBSERVATION DURING THE EMERGENCY MEASURES WAS HOWEVER, NOT SEEN AS THE CAUSE FOR THE CLINICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332243 ICS 3000 OM-3 US PROGRAMMER OVJ BIOTRONIK SE & CO. KG 349530

    Patients

    Seq Age Sex Outcome Treatment
    1 Death