BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1842536 · Received September 1, 2010

    Report

    Report Number
    1644487-2010-01993
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. ANALYSIS OF PROGRAMMING HISTORY. RESULTS: X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED HIGH LEAD IMPEDANCE READINGS DURING A ROUTINE OFFICE VISIT. THE DATE OF THE LAST GOOD DIAGNOSTICS WAS (B)(6) 2009. THERE WERE NO REPORTS OF PT MANIPULATION OR TRAUMA. X-RAYS WERE TAKEN AND SENT TO THE MANUFACTURER FOR REVIEW. THE CONNECTOR PIN APPEARED TO BE FULLY INSERTED INTO THE GENERATOR. STRAIN RELIEF WAS PRESENT BUT NOT PER LABELING AS THERE WAS NO LOOP AND ONLY ONE TIE-DOWN WAS UTILIZED. NO OBVIOUS LEAD DISCONTINUITIES OR ACUTE ANGLES WERE OBSERVED IN THE PORTIONS OF THE LEAD BODY THAT COULD BE ASSESSED. THERE WAS SOME LEAD BEHIND THE GENERATOR, AND HENCE THAT REGION OF THE LEAD COULD NOT BE ASSESSED. A BATTERY LIFE CALCULATION WAS PERFORMED USING THE PT'S DATA IN THE IN-HOUSE DATABASE AND THE DEVICE IS NOT BELIEVED TO BE AT END OF SERVICE. REVISION SURGERY IS LIKELY HOWEVER IT HAS NOT YET OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 102 015790

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR