BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1172179 · Received September 11, 2008

    Report

    Report Number
    1644487-2008-02232
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 29, 2008
    Report Date
    June 7, 2021
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: REVIEW OF X-RAYS BY THE MFR REVEALED A GROSS LEAD DISCONTINUITY. CONCLUSIONS: DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR THAT THE VNS PT WAS SEEN FOR A FOLLOW UP VISIT, DUE TO WORSENING DEPRESSION OVER THE LAST TWO WEEKS, AND PAIN IN THE CHEST. THE PT HAS DENIED ANY RECENT TRAUMA, HOWEVER, THE PATIENT MENTIONED THAT SHE MOWS THE LAWN, WHICH IS ON A VERY STEEP INCLINE AND EXPERIENCED THE CHEST PAIN DURING THIS ACTIVITY. DIAGNOSTIC TESTING WAS PERFORMED AND REVEALED HIGH LEAD IMPEDANCE, END OF SERVICE STATUS SET TO NO. THE PHYSICIAN SUBSEQUENTLY DISABLED THE DEVICE. X-RAYS WERE SENT TO MANUFACTURER TO REVIEW, AND A LEAD DISCONTINUITY WAS OBSERVED FOLLOWING THE FOURTH TIE-DOWN AFTER THE STRAIN RELIEF LOOP IN THE NECK REGION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FOR THE TREATING PHYSICIAN HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 1188

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention