BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2150561 · Received June 22, 2011

    Report

    Report Number
    3007566237-2011-04675
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BRIDGE BOLUS WAS NOT PERFORMED WHEN OLD CONC: 500MCG/ML (PROGRAMMED), NEW CONC: 2000MCG/ML AND NEW DOSE 250MCG/DAY (PROGRAMMED) WITH FLOW RATE .020ML/HR. THE DRUG WAS BACLOFEN (LIORESAL) AND IT HAS BEEN INFUSING FOR 2 HR. 0.0416ML WAS DELIVERED. TTV: .335 ML - 0.0416ML = .293ML LEFT TO BRIDGE. SINGLE BOLUS: 586MCG. DURATION 14HRS 3 MIN. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR CATHETER: MODEL 8711, LOT # N176161012| IMPLANTED:| EXPLANTED: