BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOBELLE INSTITUTE PHRENIC NERVE PACER

    MDR report key: 303989 · Received October 26, 2000

    Report

    Report Number
    MW4002888
    Event Type
    Injury
    Date Received
    October 26, 2000
    Manufacturer
    DOBEL INSTITUTE, INC.
    Product Code
    GZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLICATION OF THE PHRENIC NERVE PACER AS PROVIDED BY THE DOBELLE INSTITUTE. A BOARD-CERTIFIED OTOLARYNGOLOGIST INSERTED THE PHRENIC NERVE PACING WIRES WITHOUT INCIDENT IN A PT WITH NOCTURNAL HYPOVENTILATION. BOTH DIAPHRAGMS SUCCESSFULLY PACED AT APPROXIMATELY FOUR WEEKS POST-INSERTION. UNFORTUNATELY, APPROXIMATELY FOUR WEEKS LATER THE RIGHT PHRENIC NERVE HAD COMPLETELY STOPPED WORKING TO STIMULATION AND TO SPONTANEOUS VENTILATION. THIS REQUIRED THAT THE PACING WIRE BE REMOVED. AT THE TIME OF THE REMOVAL OF THE RIGHT PHRENIC NERVE PACING WIRE FROM ITS ATTACHMENT TO THE PHRENIC NERVE, THERE WAS NO APPARENT DAMAGE OR INFLAMMATION AT THE SITE OF THE PHRENIC NERVE. TO DATE THERE HAS BEEN NO RECOVERY IN THE RIGHT PHRENIC NERVE WITH CONSEQUENT MILD PARADOXICAL MOTION. THIS IS A DISASTROUS EVOLUTION IN A PT WITH CENTRAL HYPOVENTILATION SYNDROME WHO ONLY REQUIRED THE PHRENIC NERVE PACERS AT NIGHTTIME. RPTR IS UNCERTAIN AS TO WHAT TO DO ABOUT PACING THE OTHER STILL-NORMAL PHRENIC NERVE AND HAVE RECEIVED LITTLE OR NO INSTRUCTIONS FROM THE DOBELLE INSTITUTE IN THAT REGARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOBELLE INSTITUTE PHRENIC NERVE PACER PHRENIC NERVE PACER GZE DOBEL INSTITUTE, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO