BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALOS SLR

    MDR report key: 3252086 · Received July 29, 2013

    Report

    Report Number
    1028232-2013-02079
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 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 REVEALING SCRATCHES ON THE PACEMAKER HOUSING. THE HEADER OF THE PACEMAKER WAS MECHANICAL ANALYSED, REVEALING NO ANOMALIES. THE SET SCREW COULD BE EASILY SCREWED IN AND OUT, THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORE. ALL DIMENSIONS OF THE HEADER BORE WERE WITHIN THE RANGE REQUESTED BY THE IS-1 STANDARD SPECIFICATIONS. ALSO THE SPRING ELEMENT OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS. THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE PACEMAKER WAS INTERROGATED AND THE PACEMAKER¿S MEMORY CONTENT WAS ANALYSED INDICATING NO DEVIATIONS. THE BATTERY WAS FOUND TO BE FULLY CHARGED. 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. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. ADDITIONALLY, A LONG-TERM PACING TEST WAS PERFORMED. THE THERAPY FUNCTIONALITY OF THE PACEMAKER 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 - IT WAS REPORTED THAT THE DEVICE EXHIBITED VENTRICULAR UNDERSENSING AFTER A P-WAVE. THE PACEMAKER WAS REPLACED AND A NEW LEAD WAS IMPLANTED. NO INFORMATION ON THE LEAD IS AVAILABLE, OTHER THAN IT WAS CAPPED. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353859 TALOS SLR PACEMAKER DXY BIOTRONIK SE & CO. KG 356252

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization