BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2043100 · Received March 25, 2011

    Report

    Report Number
    1644487-2011-00644
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    October 11, 2010
    Report Date
    February 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THROUGH A COMPANY REPRESENTATIVE THAT HE SHOWED CONCERN WITH A PATIENT'S EOS PROJECTION AS THE DEVICE INDICATED 3 MONTHS UNTIL EOS = YES. THE NEUROLOGIST BELIEVED THE END OF SERVICE OF THE DEVICE "SEEMED FAST" AND HE THOUGHT THE GENERATOR SHOULD LAST LONGER THAN JUST 2 YEARS. MOREOVER, THE PROJECTED BATTERY LIFE WAS COMPARED USING THE END OF SERVICE EXPECTATIONS CHART. ADDITIONALLY, HIGH DUTY CYCLES, LIKE HIGHER STIMULATION PARAMETERS, RESULT IN REDUCED BATTERY LONGEVITY IN ALL GENERATORS. FURTHER INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE INDICATING THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER AND UNDERWENT ANALYSIS. ANALYSIS OF THE GENERATOR REVEALED THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS AND REVEALED THAT 102.655% OF THE BATTERY HAD BEEN CONSUMED. THE BATTERY VOLTAGE VALUE STORED WITHIN THE GENERATOR (2.243 VOLTS) SUGGESTS THE DEVICE IS AT AN END-OF-SERVICE CONDITION. A CAUSE FOR THE OUT OF SPECIFICATION C4 CAPACITOR (V CPU) VALUE WAS NOT DETERMINED. THIS COMPONENT IS USED AS A FILTER CAPACITOR FOR THE MICROPROCESSOR VOLTAGE AND IS NOT EXPECTED TO HAVE AN ADVERSE EFFECT ON BATTERY LONGEVITY. THE FINAL ELECTRICAL TEST PERFORMED IN PA DEMONSTRATES THAT THE LOWER VALUE OF CAPACITOR HAD NO ADVERSE EFFECT ON FUNCTIONALITY OF THE PULSE GENERATOR. VISUAL INSPECTION RESULTS REVEALED NO EXTERNAL DEVICE ABNORMALITIES. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 LYJ CYBERONICS, INC. 104 200859

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR