BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1922713 · Received November 12, 2010

    Report

    Report Number
    1644487-2010-02563
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE SURGEON THAT THE PT WAS TAKEN INTO THE OPERATING ROOM FOR A REGULAR END OF LIFE BATTERY REPLACEMENT SURGERY. SURGEON STATED THAT WHEN HE CONNECTED THE NEW GENERATOR TO THE EXISTING LEAD, HE GOT HIGH LEAD IMPEDANCE WARNING. A LEAD BREAK COULD NOT BE VISUALIZED. THE SURGEON TRIED RE-SEATING THE PIN INTO THE GENERATOR, BUT GOT SAME RESULTS. FOLLOW UP WITH THE TREATING PHYSICIAN REVEALED THAT THE DIAGNOSTICS PRIOR TO THE SURGERY WERE WITHIN NORMAL LIMITS. THE SURGEON DECIDED TO HAVE A FULL REVISION SURGERY. EXPLANTED LEAD WAS RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS WAS COMPLETED ON THE LEAD AND THE REPORTED EVENT CONFIRMED. A LEAD BREAK WAS IDENTIFIED AT THE NEGATIVE ELECTRODE QUADFILAR COIL. EXCESSIVE PITTING WAS FOUND AT THE BREAK LOCATION. NO OTHER OBVIOUS ANOMALIES WERE NOTED. (B)(4) ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR