BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 4210998 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003809
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 15, 2014
    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, THE LEAD PROPERTIES WERE CHECKED. IN THE RETURNED STATE, THE LEAD WAS DESTROYED. THE LEAD HAD BEEN CUT THROUGH 6 CM DISTAL OF THE IS-1 CONNECTOR PIN, PROBABLY WITH A SCALPEL. ASIDE FROM THE CONNECTOR, A 14 CM LONG LEAD FRAGMENT FROM THE MIDDLE PART OF THE LEAD WAS ALSO AVAILABLE. THE REMAINING SEGMENTS WERE NOT AVAILABLE FOR ANALYSIS. ASIDE FROM THE SEPARATION OF THE LEAD, NO OTHER DAMAGE COULD BE NOTED. THE ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS OF THE AVAILABLE IEGMS COULD CONFIRM THE CLINICAL OBSERVATION BUT THERE WERE NO INDICATIONS OF A MALFUNCTION OF THE ICD. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN ESTIMATED IMPLANTATION TIME OF ABOUT 93 MONTHS, INAPPROPRIATE SHOCK DELIVERY WAS REPORTED. THE LEADS WERE REPLACED AND RETURNED TO BIOTRONIK FOR ANALYSIS. THE ICD IS STILL ACTIVELY IMPLANTED. NO WORSENING OF THE PATIENT'S HEALTH WAS REPORTED APART FROM THE SHOCK DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692037 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization