BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1761282 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01628
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PT PRESENTED AT THE ER ON (B)(6) IN AN UNRESPONSIVE STATE. THERE WAS INITIAL QUESTION OF A DRUG OVERDOSE; HOWEVER THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND BECAUSE OF WORSENING MENTAL STATUS AND A SUSPICION OF STATUS EPILEPTICUS, THE PT WAS INTUBATED AND PLACED ON MECHANICAL VENTILATION. FURTHER FOLLOW UP WITH THE PT'S NEUROLOGIST REVEALED THAT THE PT STOPPED TAKING HIS SEIZURE MEDICATIONS AT HIS OWN ACCORD, NOT AT THE NEUROLOGIST'S RECOMMENDATION, AND AS A RESULT THE PT WENT INTO STATUS EPILEPTICUS. THE PT WAS STABILIZED AND TRANSFERRED TO THE PSYCHIATRIC WARD ON (B)(6) AND WAS MONITORED BY NEUROLOGY FOR SEIZURES, AND PSYCHIATRY FOR DEPRESSION. PRIOR TO THE ADMISSION TO THE PSYCHIATRIC WARD, THE PT HAD BEEN RESTRAINED DUE TO THE WORSENING MENTAL STATUS. THE EVENTS WHICH LED TO THE ER VISIT WERE PRECEDED BY CONTRIBUTORY EVENTS THAT OCCURRED IN HIS PERSONAL LIFE (SEPARATION WITH HIS SPOUSE). THE PTS VNS DEVICE WAS CHECKED BY HIS NEUROLOGIST ON (B)(6), AND A SYSTEM DIAGNOSTIC TEST REVEALED HIGH LEAD IMPEDANCE, DCDC = 7. THE PHYSICIAN HAS OPTED TO KEEP THE DEVICE PROGRAMMED ON, AS IT IS FELT THAT THE PT IS STILL RECEIVING THERAPEUTIC BENEFIT FOR CONTROLLING HIS SEIZURES. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6). THE PT HAS RELOCATED TO A NEW AREA AND IS SEEING A NEW NEUROLOGIST. THE NEW PHYSICIAN HAS REFERRED THE PT TO A SURGEON WHERE REVISION SURGERY IS LIKELY. X-RAYS WILL NOT BE TAKEN TO ASSESS THE CONTINUITY OF THE DEVICE. IT IS SUSPECTED BY THE PREVIOUS NEUROLOGIST THAT THE LEAD MAY HAVE BEEN DAMAGED WHEN THE PT WAS RESTRAINED, AS THEY HAD RESTRAINED THE PT'S NECK AT THE HOSPITAL. THE LAST DIAGNOSTIC TEST RESULTS PRIOR TO WHEN THE HIGH IMPEDANCE WAS NOTED WAS DONE IN (B)(6) 2010 WHICH REVEALED NORMAL DEVICE FUNCTION AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1955

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR