BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/18

    MDR report key: 3003340 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00291
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 29, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Additional Manufacturer Narrative · 1

    DURING THE ANALYSIS OF THE LEAD, FRAYING OF THE INSULATION WAS NOTED IN THE PROXIMAL ZONE OF THE LEAD, AS WELL AS FRAYING OF THE COATING OF THE ROPE CONDUCTOR TO THE RV SHOCK COIL AT JUST THAT SITE. INDICATIONS OF AN ELECTRICAL SPARKOVER WERE VISIBLE ON THE ROPE CONDUCTOR. THE ANALYSIS DID NOT INDICATE A MATERIAL DEFECT OR MANUFACTURING ERROR. RATHER, THE DAMAGE MANIFESTATION POINTS TOWARD SIGNIFICANT MECHANICAL STRESS DURING THE OPERATING TIME. 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 FRICTION AT THE ICD HOUSING. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH COULD PROVIDE INFORMATION ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS. THE DAMAGE TO THE PROXIMAL SHOCK COIL IS PROBABLY A RESULT OF THE EXPLANTATION PROCESS.

    Description of Event or Problem · 1

    OUR MDR - AFTER AN IMPLANTATION TIME OF ABOUT 13 MONTHS, AN INSULATION DEFECT WITH SPARKOVER AT SHOCK DELIVERY WAS REPORTED. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63923 LINOX SMART SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 359067

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization