BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART PROMRI S DX 65/17

    MDR report key: 3891455 · Received June 24, 2014

    Report

    Report Number
    1028232-2014-002122
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 13, 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

    THE RETURNED LEAD WAS THOROUGHLY ANALYZED. THE LEAD WAS VISUALLY, MECHANICALLY, AND ELECTRICALLY CHECKED DURING THE ANALYSIS. DURING THE VISUAL INSPECTION, CUTS WERE FOUND IN THE INSULATION THAT ARE PROBABLY A RESULT OF THE EXPLANTATION PROCESS, AS IS ALSO DESCRIBED IN THE CLINICAL COMPLAINT. IN THE FURTHER COURSE, A BENT IS-1 CONNECTOR PIN WAS IDENTIFIED. THE ANALYSIS SHOWED THAT THE CAUSE IS PROBABLY THE MECHANICAL STRESS DURING THE APPLICATION OF THE TURNING AID. THE INSPECTION SHOWED ALSO DAMAGE NEAR THE IS-1 CONNECTOR PIN, WHERE A TWISTED INNER CONDUCTOR HELIX AS RESULT OF EXCESSIVE MECHANICAL STRAIN WAS LATER DETECTED. THE ANALYSIS SHOWED THAT OVERROTATION OF THE SCREW MECHANISM SHOULD BE CONSIDERED AS THE CAUSE. IN SUMMARY, CUTS WERE FOUND IN THE INSULATION. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 4 WEEKS, THE RV LEAD WAS OVERSENSING, BUT NO SHOCK WAS DELIVERED. UPON REVISION, THE PHYSICIAN HAD ACCIDENTALLY CUT INTO THE LEAD, AND IT HAD TO BE EXPLANTED. IT WAS ALSO REPORTED THAT NO IRREGULARITIES WERE FOUND AFTER PERFORMING A PROVOCATION TEST. IMPEDANCE AND SENSING VALUES WERE WITHIN NORMAL RANGE. NO WORSENING OF THE PATIENT'S HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368624 LINOX SMART PROMRI S DX 65/17 ICD LEAD NVY BIOTRONIK SE & CO. KG 377212

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization