BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 3063334 · Received April 17, 2013

    Report

    Report Number
    1644487-2013-01046
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAD BEEN MADE AT THE TIME OF THE INITIAL REPORT BUT THAT INFORMATION WAS NOT COMMUNICATED ON THE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A VNS CONSULTANT REPORTED THAT HE WAS NOT ABLE TO INTERROGATE A PATIENT'S DEVICE DUE TO SUSPECTED BATTERY DEPLETION. THE PATIENT WAS GOING IN FOR A GENERATOR REPLACEMENT SURGERY. AFTER THE OLD GENERATOR WAS EXPLANTED AND THE NEW GENERATOR WAS CONNECTED TO THE EXISTING LEAD, THE CONSULTANT WAS INFORMED THAT HIGH IMPEDANCE WAS OBSERVED ON THE NEW GENERATOR IN THE OPERATING ROOM. THE CONSULTANT SUGGESTED DISCONNECTING THE LEAD PIN FROM THE GENERATOR, CLEANING IT, AND REINSERTING IT BACK INTO THE GENERATOR. AFTER THIS WAS PERFORMED, HIGH IMPEDANCE WAS OBSERVED AGAIN. THE GENERATOR WAS TESTED USING A GENERATOR DIAGNOSTICS TEST AND RESULTS WERE WITHIN NORMAL LIMITS. THE SURGERY WAS ENDED BECAUSE THE SURGEON DOES NOT PERFORM A SYSTEM REVISION DUE TO POSSIBLE TRAUMA TO THE NECK. THE CONSULTANT DID NOT KNOW IF THE NEW GENERATOR WAS LEFT IMPLANTED IN THE PATIENT OR IF THE OLD GENERATOR WAS LEFT IMPLANTED IN THE PATIENT. THE PATIENT PRIOR TO THE SURGERY REPORTED THAT THE BATTERY IN HER DEVICE HAD BEEN DEAD FOR A FEW MONTHS AND THAT SHE WAS SUPPOSED TO HAVE A NEW GENERATOR IMPLANTED LAST YEAR BUT THE SURGERY WAS CANCELED BECAUSE OF HER HAVING ANOTHER SURGERY UNRELATED TO VNS. THERE WAS NO TRAUMA OR PATIENT MANIPULATION THAT MAY HAVE CONTRIBUTED TO THE HIGH IMPEDANCE THAT WAS OBSERVED IN THE OPERATING ROOM.

    Description of Event or Problem · 1

    ATTEMPT FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE AND NOT ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS NOT GOING TO UNDERGO BATTERY CHANGE OR ANYTHING ELSE RELATED.

    Description of Event or Problem · 1

    DURING THE BATTERY REPLACEMENT SURGERY, THE LEADS WERE FOUND TO BE CORRODED AND THERE WAS BROWN FLUID IN THE SURROUNDING AREA, SO THE SURGEON CUT THE LEADS AND REMOVED THE BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166217 LEAD MODEL UNK LEAD MODEL UNK MUZ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR