BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N'VISION

    MDR report key: 1025561 · Received April 4, 2008

    Report

    Report Number
    2182207-2008-01805
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO PUMP REPLACEMENT SURGERY, THE PATIENT HAD BEEN RECEIVING LIORESAL 2000 MCG/ML AT A RATE OF 600 MCG/DAY. DURING THE REPLACEMENT SURGERY, THE ORIGINAL CATHETER WAS FOUND TO BE SHEARED. SEE MANUFACTURER'S REPORT # 6000030-2008-01763. BECAUSE OF THE SHEARED CATHETER, THE HCP LOWERED THE PATIENT'S DOSE OF LIORESAL TO 100 MCG/DAY AFTER THE PUMP AND CATHETER REPLACEMENT. THE PATIENT WENT HOME AFTER SURGERY AND WAS DOING WELL. THREE DAYS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER PASSING OUT. THE PATIENT HAD AN OVERDOSE WITH THE FOLLOWING SYMPTOMS: HYPOTENSION, A HEADACHE, NAUSEA, AND VOMITING. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PUMP WAS SET TO MINIMUM RATE. DURING THE PATIENT'S HOSPITALIZATION, SHE WAS TREATED WITH A BLOOD PATCH FOR A SPINAL LEAK. SEE MANUFACTURER'S REPORT # 6000030-2008-01804. THE PATIENT WAS DISCHARGED TO HOME ON MONDAY AFTERNOON AND WAS 'MUCH IMPROVED'. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N'VISION LKK MEDTRONIC NEUROMODULATION 8840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED| CATHETER MODEL # 8709SC| LOT # NGP313150H| IMPLANTABLE INFUSION PUMP MODEL 8637| IMPLANTED| EXPLANTED