BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2841682 · Received October 24, 2012

    Report

    Report Number
    1028232-2012-02630
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 11, 2012
    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

    OUS MDR.

    Additional Manufacturer Narrative · 1

    AS PART OF THE ANALYSIS OF THE LEAD WAS OBSERVED THAT THE INSULATION WAS DAMAGED BY WEAR-THROUGH. THIS DAMAGE IS TO BE REGARDED WITH HIGH PROBABILITY AS THE CAUSE OF THE CLINICAL COMPLAINT. THE OBSERVED TYPE OF DAMAGE REQUIRES A LOAD ON THE LEAD OVER AN EXTENDED PERIOD OF TIME. X-RAYS OR DIAGNOSTIC IMAGES OF ANOTHER KIND WHICH SHOW THE RELATIVE POSITIONS OF THE IMPLANTED SYSTEM, WERE NOT AVAILABLE FOR ANALYSIS. FURTHERMORE, IT WAS FOUND IN THE ANALYSIS OF THE LEAD, THAT THE CABLE LEAD 9 CM DISTAL TO THE CONNECTOR PINS WAS BROKEN TO THE RV SHOCK COIL. IT IS THEREFORE LIKELY THAT STRONG TENSILE FORCES LED TO THIS DAMAGE DURING EXPLANTATION. THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF 43 MONTHS, AN INAPPROPRIATE SHOCK DELIVERY WAS REPORTED. NO DETERIORATION IN THE PT'S STATE OF HEALTH WAS REPORTED. THE DEVICE WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization