BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART PROMRI S 65

    MDR report key: 4211003 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003810
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 16, 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, DEFORMATIONS OF THE RV SHOCK COIL WERE FOUND, WHICH WERE PROBABLY CAUSED BY THE EXPLANTATION PROCESS. THE ANALYSIS DID NOT SHOW ANY FURTHER DEVIATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE MEASUREMENT VALUES OF THE ELECTRICAL AND MECHANICAL 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 - THE PACING THRESHOLD WAS REPORTED TO HAVE INCREASED TO 4.4 V WITHIN ONE WEEK. SENSING VALUE WAS 6.2 MV. NO WORSENING OF THE PATIENT¿S HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692409 LINOX SMART PROMRI S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 377166

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization