BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 100

    MDR report key: 1032586 · Received April 21, 2008

    Report

    Report Number
    1644487-2008-00965
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PULSE GENERATOR WAS RETURNED TO MFR FOR ANALYSIS AFTER BEING EXPLANTED FOR END OF BATTERY LIFE. PRODUCT ANALYSIS IDENTIFIED A COMPONENT FAILURE OF THE REED SWITCH. THE REPORTED ISSUE, END OF BATTERY LIFE WAS NOT CONFIRMED. AS-RECEIVED, THE DEVICE DID NOT DELIVER THE PROGRAMMED OUTPUT CURRENT OR THE PROGRAMMED MAGNET CURRENT WITH MAGNET ACTIVATION. ANALYSIS DETERMINED THAT THE REED SWITCH WAS OPEN AND THAT THE OBSERVED NO OUTPUT CONDITION DURING THE PRODUCT ANALYSIS WAS ISOLATED TO A DEFECTIVE REED SWITCH, WHICH WAS NOT CLOSING PROPERLY. A DEVICE MALFUNCTION OCCURRED AGAINST THE REED SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 100 LYJ CYBERONICS, INC. 100 30980C

    Patients

    Seq Age Sex Outcome Treatment
    1