BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 1935160 · Received December 6, 2010

    Report

    Report Number
    1028232-2010-02666
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 26, 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. ONLY THE PROXIMAL PARTS WERE RECEIVED. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE SURGERY. DUE TO THE DAMAGES, THE ELECTRICAL INSPECTION OF THE LEAD WAS LIMITED TO THE DC RESISTANCES OF THE LEAD FRAGMENTS. NO PECULIARITIES WERE FOUND. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 29 MONTHS, INAPPROPRIATE SHOCKS WERE DELIVERED MORE THAN 10 TIMES DUE TO OVERSENSING. THE PHYSICIAN CONFIRMED DAMAGE OF THE LEAD INSULATION, OVERSENSING DUE TO THE LEAD, THRESHOLD INCREASE AND INCREASE IN THE LEAD IMPEDANCE. NOISE WAS ALSO OBSERVED WHEN THE SENSING/PACING LEAD WAS MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization