BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4162145 · Received October 10, 2014

    Report

    Report Number
    1644487-2014-02617
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    October 30, 2012
    Report Date
    January 5, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT #2 INADVERTENTLY OMITTED THE INFORMATION THAT THE EXPLANTED DEVICES WERE DISCARDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A PAINFUL EVENT WHERE THE GENERATOR FELT AS THOUGH IT HAD TURNED IN HER CHEST AND SINCE THEN, THE PATIENT HAS EXPERIENCED MORE DEPRESSIVE EPISODES. THE PATIENT FEELS THAT THE GENERATOR BATTERY MAY BE RUNNING LOW. THE PATIENT WAS GIVEN A NAME OF A PHYSICIAN TO HAVE THE DEVICE CHECKED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY. REVIEW OF THE REFERRAL CLINIC NOTES SHOWED A DC-DC CODE OF (B)(4) DURING THE OFFICE VISITS, WHICH WAS BELIEVED TO BE WITHIN NORMAL LIMITS AT THE TIME OF REVIEW. DURING THE REPLACEMENT SURGERY, THE PATIENT¿S NEW M103 GENERATOR REGISTERED LOW IMPEDANCE. THE PATIENT WAS REPORTEDLY A TWIDDLER, AND THE SURGEON OBSERVED THAT THE LEAD WAS BROKEN AS A RESULT. THE LEAD WAS ALSO REPLACED AT THAT TIME. THE EXPLANTED LEAD HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED PRODUCTS WERE REPORTED TO HAVE BEEN DISCARDED BY THE EXPLANTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644168 LEAD MODEL 302 LEAD MUZ CYBERONICS, INC. 302-20 1300

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR