BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063778 · Received April 15, 2011

    Report

    Report Number
    3007566237-2011-02850
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 2, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS LETHARGIC 7-10 DAYS AFTER THE PUMP WAS REFILLED. ON (B)(6) 2011, THE PT WAS ADMITTED TO THE ICU; THIS WAS 15 DAYS AFTER A PUMP REFILL. THE PT WAS FLACCID AND SOMNOLENT. THE PUMP WAS INTERROGATED AND THE SYS WAS "RUNNING FINE." THE BACLOFEN WAS WITHDRAW FROM THE PUMP AND THE PUMP WAS PROGRAMMED TO STOPPED MODE. THE BACLOFEN WAS SENT TO THE LAB FOR ANALYSIS AND NO ABNORMALITIES WERE FOUND. THEY HAD ALSO DONE A TOXICOLOGY SCREEN AND AN MRI BUT NOTHING WAS FOUND. THREE DAYS LATER, THE PT WAS NO LONGER FLACCID, BUT HAD STILL NOT WOKEN UP. THE PT WAS STILL SPASTIC AND HAD RENAL FAILURE. THE PHYSICIAN BELIEVED THAT THE PT HAD A BACLOFEN OVERDOSE; HE FELT THE PT MAY BE HYPERSENSITIVE TO THE BACLOFEN (PT WAS ONLY GETTING 14 MCG/DAY). THEY REFILLED THE PUMP WITH FRESH BACLOFEN AND WITHIN 3 DAYS ALL OF THE PT'S SYMPTOMS WERE GONE. THE PT WAS BACK TO HER DOSAGE OF 14 MCG/DAY OF COMPOUNDED BACLOFEN WITH A CONCENTRATION OF 250 MCG/ML. THE PT LEFT THE HOSP FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L