BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 65/16 STEROID

    MDR report key: 1902814 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02315
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    June 16, 2010
    Report Date
    October 12, 2010
    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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED SOME 26 CM DISTAL TO THE IS-1 CONNECTOR PIN. ONLY THE PROXIMAL PART WAS RECEIVED. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE LEAD EXPLANTATION. DUE TO THE DAMAGES AN ELECTRICAL INSPECTION OF THE LEAD WAS LIMITED TO THE DC RESISTANCES OF THE LEAD FRAGMENT. NO PECULIARITIES WERE FOUND.

    Description of Event or Problem · 1

    INAPPROPRIATE SHOCKS WERE REPORTED. THE IMPLANTATION TIME IS UNKNOWN. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD AND THE ICD WERE EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization