BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 65/16 STEROID

    MDR report key: 4110335 · Received September 23, 2014

    Report

    Report Number
    1028232-2014-003383
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 96 MONTHS, OVERSENSING WAS REPORTED AND LEAD FAILURE WAS SUSPECTED. ALL ELECTRICAL PARAMETERS WERE IN RANGE. AS THE EF HAS BEEN INCREASING FOR THE PAST YEARS SINCE THE FIRST ICD HAD BEEN IMPLANTED (58 % LAST ECHO) AND AS THE PATIENT DID NOT HAVE ANY CARDIOMYOPATHY NOR ISCHEMIC HEART DISEASE, THE PHYSICIAN DECIDED TO TURN OFF THE DEVICE. THE LEAD IS STILL IMPLANTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591887 KENTROX SL 65/16 STEROID ICD LEAD NVY BIOTRONIK SE & CO. KG 347351

    Patients

    Seq Age Sex Outcome Treatment
    1 Other