BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART PROMRI S DX 65/15

    MDR report key: 3201587 · Received July 2, 2013

    Report

    Report Number
    1028232-2013-01838
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 21, 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, THE LEAD PROPERTIES WERE CHECKED. THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE CUTS IN THE INSULATION WERE WITH HIGH PROBABILITY CAUSED DURING THE EXPLANTATION PROCEDURE. THE MANUFACTURING PROCESS OF THE LEAD AND THE ICD WAS REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 3 1/2 MONTHS, OVERSENSING WITH INAPPROPRIATE SHOCK WAS REPORTED. NO OTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301586 LINOX SMART PROMRI S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 377211

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization