BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 1902836 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02377
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    July 9, 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 AND CONSISTED OF TWO LEAD FRAGMENTS. THE LEAD HAD BEEN CUT 13 CM DISTAL OF THE CONNECTOR PIN, PROBABLY WITH A SCALPEL. THE ANALYSIS FOUND FRAYING OF THE INSULATION 19 CM DISTAL OF THE CONNECTOR PIN, AS WELL AS FRAYING OF THE COATING OF THE ROPE CONDUCTOR TO THE RING ELECTRODE AT JUST THAT SITE. THIS DAMAGE MANIFESTATION CAN, WITH HIGH PROBABILITY, BE REGARDED AS THE CAUSE FOR THE CLINICAL COMPLAINT. THE FRAYING OF THE INSULATION REQUIRES EXCESSIVE MECHANICAL STRESS ON THE LEAD. THE POSITION AND CHARACTERISTICS OF THE FRAYING LEAD TO THE ASSUMPTION OF A SIMULTANEOUS OCCURRENCE OF STRONG PRESSURE OF THE LEAD ONTO THE ICD HOUSING AND EXCESSIVE FRICTION OF THE LEAD AT THE ICD HOUSING. THIS IS CONSISTENT WITH THE OBSERVED SPARKOVER TRACE AT THE ICD HOUSING. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH COULD PROVIDE INFO ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS. THE DEFORMATION OF THE VCS SHOCK COIL AND CUTS IN THE INSULATION ARE PROBABLY A RESULT OF THE EXPLANATION PROCESS. A MANUFACTURING ERROR OR MATERIAL DEFECT WAS NOT FOUND ON EITHER THE LEAD OR THE ICD.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 29 MONTHS, THIS SYSTEM WAS EXPLANTED DUE TO INAPPROPRIATE SHOCK DELIVERIES. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization