BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 65/18 STEROID

    MDR report key: 1890570 · Received October 29, 2010

    Report

    Report Number
    1028232-2010-02254
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    May 26, 2010
    Report Date
    September 30, 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

    OUS MDR - THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS OF THE LEAD DEMONSTRATED A RUBBED THROUGH INSULATION. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED OVERSENSING ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THESES DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO ABNORMAL MECHANICAL STRESS IN THE IMPLANTED STATE. THE INTERACTION WITH THE TRICUSPID VALVE SHOULD BE TAKEN INTO CONSIDERATION. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE DAMAGED LEAD TIP AND THE DEFORMATION OF THE CONDUCTOR CABLES TO THE DF-1 CONNECTORS RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - THIS LEAD WAS EXPLANTED DUE TO INAPPROPRIATE SHOCKS WERE REPORTED. THE DATE OF IMPLANT WAS NOT PROVIDED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX SL 65/18 STEROID ICD LEAD LWS BIOTRONIK SE & CO. KG 347352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization