BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1943893 · Received December 1, 2010

    Report

    Report Number
    1644487-2010-02705
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT SHOWED HIGH LEAD IMPEDANCE DURING DIAGNOSTICS TEST. NO TRAUMA OR MANIPULATION CONTRIBUTED TO THE ONSET OF THE EVENT; HOWEVER, CLINIC NOTES STATED THAT THE PT HAS DROP SEIZURES AND KEEPS HURTING HERSELF. PT WAS REFERRED FOR FULL REVISION SURGERY. LAST ACCEPTABLE DIAGNOSTICS WERE OBTAINED ON (B)(6) 2010. PT UNDERWENT A FULL REVISION SURGERY. EXPLANTED LEAD WAS RETURNED TO MFR FOR ANALYSIS. ANALYSIS IS CURRENTLY PENDING ON THE RETURNED LEAD. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200382

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR