BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGO PROMRI S 65

    MDR report key: 5885524 · Received August 18, 2016

    Report

    Report Number
    1028232-2016-02814
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 15, 2016
    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

    AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGH OUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF PHRENIC NERVE STIMULATION. THE THRESHOLD IS INCREASED. AT THE IMPLANT IT WAS LESS THAN 1V X 0.4 NOW IT IS 2,8V X 1,5 MS. THE SENSING AND IMPEDANCE TRENDS WERE STABLE. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION AND WILL BE MONITORED BY HOME MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537814 PROTEGO PROMRI S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 394099

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization