BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTELLA DR-T PROMRI

    MDR report key: 3200343 · Received July 1, 2013

    Report

    Report Number
    1028232-2013-01808
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 18, 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

    UPON RECEIPT, THE PACEMAKER WAS VISUALLY INSPECTED, PARTICULARLY THE HEADER OF THE DEVICE. THE INSPECTION DID NOT REVEAL ANY 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 SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE PACEMAKER WAS INTERROGATED AND THE PACEMAKER'S MEMORY CONTENT WAS ANALYSED DOCUMENTING THAT THE LEAD POLARITIES WERE UNIPOLAR WITH EXPECTED IMPEDANCE VALUES WHEREAS THE BIPOLAR LEAD CONFIGURATION SHOWED VALUES > 2500 OHMS. 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. IN THE FURTHER COURSE OF ANALYSIS THE IMPEDANCE MEASUREMENT FUNCTIONS OF THE DEVICE WERE TESTED USING DIFFERENT TEMPERATURE ENVIRONMENTS. HOWEVER, THE IMPEDANCE MEASUREMENT FUNCTIONS PROVED TO BE FLAWLESS. 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

    OUS MDR - 2 DAYS POST IMPLANT AN IMPEDANCE OF >2500 OHM AND WITH NO EFFECTIVE CAPTURE AT MAXIMUM OUTPUT WAS NOTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300208 ESTELLA DR-T PROMRI PACEMAKER DXY BIOTRONIK SE & CO. KG 377383

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization