BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1091608 · Received July 31, 2008

    Report

    Report Number
    1644487-2008-01752
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT UNDERWENT SURGERY DUE TO A SHOCKING SENSATION DURING VNS STIMULATION ON TIMES. THE PATIENT DID NOT RECALL ANY SPECIFIC INJURY WITH THE ONSET OF THE PAIN, BUT THE "PATIENT HAD BEEN STRUCK IN THE CHEST TWICE IN THE LAST FEW MONTHS" AND THERE WAS "EVIDENCE OF BRUISING IN THE AREA OF THE IMPLANT". DEVICE DIAGNOSTIC TESTS WERE WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION. DURING SURGERY, IT WAS FOUND THAT THE GENERATOR HAD MIGRATED SLIGHTLY AND HAD FLIPPED SIDEWAYS AND WAS NOT "FLAT IN THE CHEST POCKET." THERE WAS A SUTURE SECURING THE GENERATOR, BUT THE SURGEON REPOSITIONED AND RESUTURED THE DEVICE IN PLACE. THE SURGEON BELIEVED THE MIGRATION WAS DUE TO THE RECENT TRAUMA AND THAT THE PAIN IS PSYCHO-SOMATIC. PRE-OPERATIVE X-RAYS WERE REVIEWED BY MFR, AND NO CAUSE FOR THE REPORTED EVENT WAS SEEN. IT WAS NOTED THAT THE STRAIN RELIEF AND TIE-DOWNS WERE NOT PLACED ACCORDING TO RECOMMENDATIONS IN LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 014097

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention