BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTELLA DR

    MDR report key: 3952894 · Received July 23, 2014

    Report

    Report Number
    1028232-2014-002668
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PACEMAKER WAS VISUALLY INSPECTED REVEALING SCRATCHES ON THE PACEMAKER HOUSING. THESE WERE CONSIDERED TO BE NORMAL AND EXPECTED. THE HEADER OF THE DEVICE WAS INSPECTED REVEALING NO ANOMALIES. THE SET SCREWS COULD BE EASILY SCREWED IN AND OUT, THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORES. ALL DIMENSIONS OF THE HEADER BORES WERE WITHIN THE RANGE REQUESTED BY THE IS-1 STANDARD SPECIFICATIONS. ALSO THE SPRING ELEMENTS OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS. AT A NEXT STEP THE PACEMAKER WAS INTERROGATED AND THE PACEMAKER'S MEMORY CONTENTWAS ANALYZED INDICATING NO ANOMALIES. THE BATTERY STATUS WAS FOUND TO BE 'OK'. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. AN ADDITIONAL LONG-TERM PACING TEST WAS INITIATED. DURING THE TEST, EACH PACING PULSE WAS RECORDED. THE EVALUATION OF THESE PACING PULSES DOCUMENTED REGULAR DEVICE BEHAVIOR. NO INTERMITTENT OR PERMANENT LOSS OF OUTPUT WAS PRESENT. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS PATIENT HAD AN AORTIC VALVE REPLACEMENT ON (B)(6) 2014. AFTER THIS PROCEDURE, HIGH THRESHOLDS AND CAPTURE ISSUES IN THE ATRIAL CHANNEL WERE NOTED. THESE PERSISTED FOR SEVERAL DAYS AND A CHEST X-RAY SHOWED THAT THE LEAD WAS NOT DISLODGED. ON (B)(6) 2014, THE PHYSICIAN OPENED THE POCKET TO TEST THE RA LEAD, WHICH HAD HIGH THRESHOLDS THROUGH THE ANALYZER AS WELL. THE PHYSICIAN CAPPED THE RA LEAD AND REPLACED IT WITH A COMPETITIVE LEAD. AFTER CONNECTING THE NEW RA LEAD TO THIS DEVICE, THE PHYSICIAN NOTED LOSS OF OUTPUT IN BOTH THE RA AND RV CHANNELS WHICH RESULTED IN PACING PAUSES UP TO THREE SECONDS LONG. THE PHYSICIAN FELT THAT THIS DEVICE MIGHT HAVE BEEN DAMAGED DURING THIS SURGERY, SO A NEW DEVICE WAS IMPLANTED AND THE PACING PAUSES WERE NOT SEEN WITH THE NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430260 ESTELLA DR PACEMAKER DXY BIOTRONIK SE & CO. KG 371205

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization