BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3080794 · Received April 26, 2013

    Report

    Report Number
    1644487-2013-01178
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF DEVICE MANUFACTURING RECORDS FOR BOTH THE GENERATOR AND LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATING THE PATIENT'S DEVICE, HIGH LEAD IMPEDANCE WAS OBTAINED. IT WAS REPORTED THAT DEVICE DIAGNOSTICS WERE THEN PERFORMED AND SHOWED 2877 OHMS AND NO HIGH IMPEDANCE. SYSTEMS DIAGNOSTICS WERE AGAIN PERFORMED WITH THE PATIENT'S HEAD TURNED IN DIFFERENT POSITIONS WHICH ALL RESULTED IN HIGH IMPEDANCE >10000 OHMS. IT WAS REPORTED THAT THE DEVICE HAD JUST BEEN PROGRAMMED ON AND IT WAS RECOMMENDED THAT THE DEVICE BE PROGRAMMED BACK OFF. THE DEVICE WAS PROGRAMMED OFF AS ADVISED. IT WAS REPORTED THAT THE PATIENT WAS SEEN APPROXIMATELY TWO WEEKS FOLLOWING IMPLANT SURGERY AND THAT HIGH IMPEDANCE WAS NOT OBTAINED AT THAT TIME. THERE WAS NO BELIEVED CAUSE FOR THE HIGH LEAD IMPEDANCE AT THIS TIME, BUT THE PATIENT DOES CONTINUE TO HAVE SEIZURES. THE PATIENT WAS REFERRED TO SURGEON FOR EVALUATION. SURGERY IS SCHEDULED; HOWEVER, HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PATIENT'S DEVICE WAS PROGRAMMED OFF AFTER THE HIGH IMPEDANCE WAS OBTAINED. THE PATIENT WAS REFERRED TO SURGEON FOR REVISION SURGERY. CLINIC NOTES DATED (B)(6) 2013 CONFIRMED THAT DIAGNOSTICS WERE WITHIN NORMAL LIMITS FOLLOWED BY SEVERAL HIGH IMPEDANCE >1000 OHMS WITH THE PATIENT'S HEAD IN MULTIPLE POSITIONS. CLINIC NOTES DATED (B)(6) 2013 CONFIRMED HIGH IMPEDANCE UPON INTERROGATION. X-RAYS WERE TAKEN ON (B)(6) 2013 AND REVIEWED ON (B)(6) 2013 BY SURGEON AND DEVICE MANUFACTURER COMPANY REPRESENTATIVE WHO REPORTED THAT THE LEAD PIN WAS NOT ABLE TO BE VISUALIZED PAST THE GENERATOR CONNECTOR BLOCK. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 AT WHICH TIME PREOPERATIVE DIAGNOSTICS CONFIRMED THE HIGH IMPEDANCE. THE SURGEON DISCONNECTED THE LEAD FROM THE GENERATOR AND THEN REINSERTED THE LEAD PIN INTO THE GENERATOR HEADER. DIAGNOSTICS WERE PERFORMED THREE TIMES AFTER RE-INSERTING THE LEAD PIN INTO THE GENERATOR HEADER WHICH WERE ALL WITHIN NORMAL LIMITS. THE SURGEON COMPLETED THE SURGERY AND LEFT THE PATIENT'S DEVICE PROGRAMMED OFF AND THE PATIENT WAS REFERRED TO HER NEUROLOGIST TO HAVE THE DEVICE PROGRAMMED BACK TO ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182788 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202312

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR