BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL-S 65/16 STEROID

    MDR report key: 2243793 · Received July 29, 2011

    Report

    Report Number
    1028232-2011-01655
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BIOTRONIK SE & CO, KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF (B)(6), IT WAS REPORTED THAT THE ASSOCIATED ICD COULD NO LONGER BE INTERROGATED. NO DETERIORATION OF THE PATIENT'S HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX SL-S 65/16 STEROID ICD LEAD LWS BIOTRONIK SE & CO, KG 342397

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization