BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART PROMRI S 65

    MDR report key: 3952884 · Received July 23, 2014

    Report

    Report Number
    1028232-2014-002483
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 10, 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. DURING THE EXAMINATION, THE LEAD WAS CHECKED VISUALLY, ELECTRICALLY, AND MECHANICALLY. DURING THE VISUAL INSPECTION, CUTS WERE SEEN IN THE INSULATION AND A DEFORMATION OF THE DISTAL SHOCK COIL, WHICH WAS PROBABLY A RESULT OF THE OPERATION PROCEDURE. THE ANALYSIS DID NOT SHOW ANY OTHER DEVIATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. IN PARTICULAR, THE MEASUREMENT VALUES OF THE ELECTRICAL ANALYSIS WERE WITHIN THE TECHNICAL SPECIFICATION. IN SUMMARY, THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF APPROXIMATELY 2 MONTHS, THE SHOCK IMPEDANCE WAS REPORTED TO BE EITHER >150 OHM OR LESS THAN 25 OHM. THE CONNECTION WAS CHECKED AND IT WAS FINE. THE LEAD WAS EXPLANTED AND RETURNED TO BIOTRONIK FOR ANALYSIS. NO WORSENING OF THE PATIENT¿S HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430228 LINOX SMART PROMRI S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 377166

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization