BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2102366 · Received May 20, 2011

    Report

    Report Number
    1644487-2011-01130
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 3, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A VNS TREATING PHYSICIAN REPORTED THAT THE VNS PT PRESENTED WITH HIGH IMPEDANCE DURING THEIR LAST VISIT ON (B)(6), 2011. SYSTEM DIAGNOSTICS WERE RUN ON (B)(6) 2011, WHICH SHOWED OUTPUT = LIMIT/LEAD IMPEDANCE = HIGH/ DCDC = 7; NORMAL MODE DIAGNOSTICS SHOWED THE SAME RESULTS. THE PT IS DOING WELL WITH NO INCREASE IN SEIZURES OR PAIN. THE PT'S SETTINGS WERE 1.75/30/500/30/3 BUT THE PT WAS PROGRAMMED TO 0MA PRIOR TO LEAVING. THE PT WENT FOR X-RAYS AND THEY WERE REVIEWED BY THE MFR ON (B)(6) 2011. USING THE CURVATURE OF THE GENERATOR CAN, THE CONNECTOR PIN DID NOT APPEAR TO BE FULLY INSERTED INTO THE CONNECTOR BLOCK. FURTHERMORE, THE END OF THE CONNECTOR PIN COULD NOT BE VISUALIZED PAST THE CONNECTOR BLOCK. THERE DID NOT APPEAR TO BE ANY GROSS FRACTURES OR DISCONTINUITIES IN THE LEAD BODY; HOWEVER, THERE DID APPEAR TO BE TWO SHARP ANGLES IN THE LEAD BODY, ONE NEAR THE ANCHOR TETHER AND THE OTHER PRIOR TO THE FIRST TIE-DOWN. THERE WAS A PORTION OF THE LEAD BODY COILED BEHIND THE GENERATOR THAT WAS UNABLE TO BE ASSESSED. BASED ON THE X-RAY REVIEW, THE CONNECTOR PIN APPEARING TO NOT BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK AND THE SHARP ANGLES COULD BE THE CAUSE OF THE PT'S HIGH IMPEDANCE. NO OBVIOUS DISCONTINUITIES WERE NOTED IN THE VISUALIZED PORTION OF THE LEAD; HOWEVER, AN UNPRONOUNCED LEAD FRACTURE CANNOT BE RULED OUT. THE NURSE PRACTITIONER REPORTED THAT SHE WAS NOT AWARE OF ANY PT MANIPULATION OR TRAUMA THAT OCCURRED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S HIGH IMPEDANCE. SHE SAID THAT THE LAST TIME THE PT WAS SEEN BEFORE THE HIGH IMPEDANCE WAS DETECTED, WAS ON (B)(6) 2010, AND THE CLINIC NOTES STATE THAT THE VNS WAS INTERROGATED AND EVERYTHING WAS FOUND AS EXPECTED BUT THAT SPECIFICS WERE NOT LISTED. SURGERY IS LIKELY BUT HAS NOT YET BEEN SCHEDULED. IF ADD'L INFO IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200969

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR