BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART PROMRI S 65

    MDR report key: 3880309 · Received June 18, 2014

    Report

    Report Number
    1028232-2014-01999
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LEAD WAS THOROUGHLY ANALYZED. DURING THE ANALYSIS, THE LEAD WAS EXAMINED VISUALLY, ELECTRICALLY, AND MECHANICALLY. THE VISUAL INSPECTION DETECTED CUTS IN THE INSULATION AND A DEFORMATION OF THE DISTAL SHOCK COIL, WHICH ARE PROBABLY A RESULT OF THE EXPLANTATION. THE ONGOING ANALYSIS DID NOT SHOW OTHER DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE LEAD PROVED TO BE IN COMPLIANCE WITH SPECIFICATIONS AND IN ORDER. ALL MEASUREMENT VALUES OF THE ELECTRICAL AND MECHANICAL ANALYSIS WERE WITHIN THE TECHNICAL SPECIFICATION. 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 MONTHS, LOW SENSING VALUES (1.9 MV JUST PRIOR TO SURGERY) WERE REPORTED. A LEAD DEFECT OR INCORRECT FIXATION WAS SUSPECTED. THE LEAD WAS EXPLANTED. PATIENT'S HEALTH WAS NOT REPORTED TO HAVE WORSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357067 LINOX SMART PROMRI S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 377166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other