BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED

    MDR report key: 91830 · Received May 14, 1997

    Report

    Report Number
    6000030-1997-00166
    Event Type
    Other
    Date Received
    May 14, 1997
    Date of Event
    April 8, 1997
    Report Date
    April 9, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAS HISTORY OF HYDROCEPHALUS, AND HAD RECENTLY BEEN WEANED OFF PHENOBARBITOL FOR SEIZURE ACTIVITY. PUMP WAS IMPLANTED FOR RELIEF OF SPASTICITY, AND SUBSEQUENTLY PT HAD SERIES OF SMALL SEIZURES. THESE EVENTS CULMINATED IN PT PRESENTING IN ER WITH SEIZURES, REQUIRING EEG'S , LOWERING BACLOFEN DOSAGE, SO DOSAGE WAS LOWERED AGAIN, RESULTING IN DECREASED SEIZURE ACTIVITY, BUT INCREASED PT'S SPASTICITY. HEALTH CARE PROVIDER WAS UNSURE WHETHER PT JUST HAD EXTREME SENSITIVITY TO BACLOFEN. NO FURTHER INFO ON THIS PT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 8617-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization