BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD, UNKNOWN

    MDR report key: 4111379 · Received September 23, 2014

    Report

    Report Number
    3007566237-2014-02671
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2013 WHEN THE PATIENT HAD BEEN FIRST GETTING SET UP WITH THE DEEP BRAIN STIMULATOR (DBS) THERE WAS A PROBLEM WITH THE ANESTHESIA. THE PATIENT'S LEAD IMPLANT PROCEDURE ON (B)(6) 2013 WAS ABORTED. TWO DATES WERE GIVEN AND IT WAS UNKNOWN WHICH WAS THE CORRECT DATE FOR THE ORIGINAL ATTEMPT OF LEAD IMPLANT. IT WAS NOTED THAT THE PATIENT "ATTEMPTED TO PULL THE STEREOTACTIC HEAD FRAME FROM HIS HEAD AS HE WAS WAKING UP FROM ANESTHESIA" AND WHEN THEY HAD GONE TO WAKE THE PATIENT UP HE HAD BEEN HAVING PARANOID SCHIZOPHRENIA AND THOUGHT THE DOCTORS WERE TRYING TO HURT HIM. THIS HAD LASTED SEVERAL DAYS. IT WAS NOTED THAT THERE WAS NO SUBSEQUENT INJURY TO THE PATIENT. IT WAS FURTHER NOTED THAT THE PATIENT WOULD HAVE THE LEADS IMPLANTED UNDER GENERAL ANESTHESIA ON A LATER DATE. FOLLOWING CHANGE OF ANESTHESIA AND THE WAY THEY WERE DOING THE TEST THE PATIENT WAS ABLE TO HAVE THE DBS IMPLANTED. NO OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION AND IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589916 LEAD, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Other