BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S DX 65/17

    MDR report key: 3021833 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00796
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    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

    DURING THE ANALYSIS OF THE LEAD, FRAYING OF THE INSULATION 24 CM DISTAL OF THE IS-1 CONNECTOR PIN AND FRAYING OF THE COATING OF THE ROPE CONDUCTOR TO THE RV SHOCK ELECTRODE AT JUST THAT SITE WERE NOTED. THIS DAMAGE MANIFESTATION CAN WITH HIGH PROBABILITY BE REGARDED AS THE CAUSE FOR THE CLINICAL COMPLAINT. THE DAMAGES INDICATE 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 OF THE LEAD 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. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS FOR EITHER THE LEAD OR THE ICD.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 16 MONTHS, IT WAS REPORTED THAT THE SHOCK IMPEDANCE DETERMINED VIA HOME MONITORING WAS OUTSIDE OF THE MEASUREMENT RANGE. THE MEASUREMENTS DURING THE FOLLOW-UP DID NOT SHOW ANY ANOMALIES. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE LEAD AND THE ICD WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124648 LINOX SMART S DX 65/17 ICD LEAD NVY BIOTRONIK SE & CO. KG 365501

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization