BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3800731 · Received May 8, 2014

    Report

    Report Number
    1644487-2014-01224
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2014. IT WAS NOTED THAT THE GENERATOR WAS DISCARDED AND THEREFORE CANNOT BE RETURNED FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE VNS PATIENT DOES NOT WISH TO REPLACE HER DEVICE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE PATIENT'S HUSBAND REPORTED THAT THE PATIENT'S DEPRESSION HAS RETURNED AND THEY ARE UNSURE IF THE DEVICE IS WORKING. THE PATIENT'S PHYSICIAN WENT OUT OF BUSINESS AND THE PATIENT AND HUSBAND ARE LOOKING FOR A NEW PHYSICIAN TO CHECK THE VNS. THE PATIENT'S HUSBAND REPORTED THAT THE DEVICE WAS LAST CHECKED ABOUT SIX MONTHS AGO. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT WAS REFERRED FOR PROPHYLACTIC GENERATOR REPLACEMENT. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION WERE UNSUCCESSFUL. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279183 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS, INC. 102 014865

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR