BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX RV-S 65 STEROID

    MDR report key: 3232388 · Received July 18, 2013

    Report

    Report Number
    1028232-2013-01982
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 9, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LEAD WAS THOROUGHLY ANALYZED. DURING THE ANALYSIS, THE LEAD WAS CHECKED VISUALLY, ELECTRICALLY, AND MECHANICALLY. DURING THE INSPECTION, A CONDUCTOR FRACTURE OF THE ROPE CONDUCTOR TO THE RV SHOCK ELECTRODE WAS FOUND AT THE DF-1 CONNECTOR. THIS DAMAGE MANIFESTATION INDICATES SIGNIFICANT MECHANICAL STRESS IN THE IMPLANTED STATE AND CAN WITH HIGH PROBABILITY BE REGARDED AS THE CAUSE FOR THE HIGH IMPEDANCE. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH COULD PROVIDE INFORMATION ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 79 MONTHS, A SHOCK IMPEDANCE >150 OHM WAS REPORTED. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE DATE OF IMPLANT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334427 KENTROX RV-S 65 STEROID ICD LEAD NVY BIOTRONIK SE & CO. KG 343080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization