BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INFUSION PUMP

    MDR report key: 3062033 · Received April 16, 2013

    Report

    Report Number
    3007566237-2013-01313
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A BACLOFEN TRIAL APPROXIMATELY THREE WEEKS PRIOR TO THE DATE OF THIS REPORT. SINCE THE TRIAL THE PATIENT NOTED SHE HAD BEEN SICK. ON (B)(6) 2013 THE PATIENT REPORTED SHE COULD NOT WAKE UP; SHE SLEPT ALL DAY AND HAD A HORRIBLE HEADACHE AT THE BASE OF HER SKULL. THE PATIENT WAS THROWING UP AND THOUGHT SHE HAD THE FLU. THE PATIENT BELIEVED SHE HAD A FEVER; THE "FEVER BREAKS AND THEN SHE SWEATS." SHE HAD PRESSURE IN HER HEAD, "REALLY BAD BUZZING IN MY HEAD", AND VERTIGO. THE PATIENT WAS ALSO CONCERNED THAT SHE MIGHT HAVE AN INFECTION IN HER SPINAL FLUID. THE PATIENT CONTACTED HER HEALTH CARE PROVIDER (HCP); HOWEVER, THEY WERE OUT OF TOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162619 UNKNOWN INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other