BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAINOX SL 75/18

    MDR report key: 1902819 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02382
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    July 1, 2010
    Report Date
    October 21, 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

    THE LEAD WAS DESTROYED IN THE RETURNED STATE. THE LEAD HAD BEEN CUT THROUGH 5 CM AND 21 CM DISTAL OF THE CONNECTOR PIN. THE MORPHOLOGY OF THE CUTTING EDGE OF THE LEAD FRAGMENTS LEADS TO THE ASSUMPTION THAT THE LEAD HAD BEEN CUT WITH A SCALPEL DURING THE EXPLANTATION. DURING THE ANALYSIS, IT WAS NOTED THAT THE DISTAL END HAD BEEN PULLED OUT OF THE LEAD. IN ADDITION, THE INNER CONDUCTOR HELIX SHOWED SEVERE DEFORMATION AT THAT SITE. THIS DAMAGE MANIFESTATION REQUIRES EXCESSIVE MECHANICAL STRESS AND IS, WITH HIGH PROBABILITY, DUE TO STRONG TENSILE FORCES. THE MEASUREMENT OF THE DIRECT-CURRENT RESISTANCES OF THE LEAD FRAGMENTS DID NOT SHOW ANY ANOMALIES. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 71 MONTHS, THIS LEAD WAS EXPLANTED DUE TO INCREASED SHOCK IMPEDANCES. THE PACING IMPEDANCE AND THE PACE-SENSE VALUES OF THE LEAD WERE NORMAL. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAINOX SL 75/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 124217

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization