BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL-S 65/16 STEROID

    MDR report key: 2883784 · Received November 16, 2012

    Report

    Report Number
    1028232-2012-02878
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED. UPON RECEIPT, THE LEAD WAS FOUND DISSECTED AT APPROXIMATELY 17 CM DISTAL TO THE IS-1 CONNECTOR PIN INTO TWO PARTS. ALL FRAGMENTS OF THE LEAD WERE RETURNED FOR ANALYSIS. THE RETURNED LEAD FRAGMENTS WERE ANALYZED. THE INSPECTION REVEALED A RUBBED THROUGH INSULATION AT SEVERAL POSITIONS OF THE DISTAL LEAD FRAGMENT. BASED ON THE CHARACTERISTICS OF THE DAMAGES IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE ANALYSIS OF THE LEAD FRAGMENTS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO A POSSIBLE LEAD FRACTURE AND REPLACED.

    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 345988

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization