BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1884856 · Received October 15, 2010

    Report

    Report Number
    1644487-2010-02317
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING ANALYSIS OF A RETURNED GENERATOR FOR A PT, THE POSITIVE FEED-THRU CAPACITOR WAS FOUND TO BE OPEN. MANUAL MANIPULATION OF THE FEED-THRU WIRES COULD NOT DUPLICATE THE INTERMITTENT/OPEN CONDITION. WITH THE EXCEPTION OF THIS ANOMALY, THERE WAS NO OTHER CONDITION NOTED DURING THE PRODUCT ANALYSIS EVAL THAT WOULD SUGGEST ANY OTHER ANOMALY WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 412830

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR