BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063779 · Received April 15, 2011

    Report

    Report Number
    3007566237-2011-02848
    Event Type
    Injury
    Date Received
    April 15, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD A SEIZURE. THE PT WAS LETHARGIC. THE HCP PLANNED TO HAVE THE PUMP INTERROGATED. THE PUMP CONTAINED BACLOFEN 2,000 MCG/ML. ADD'L 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N058321| CATHETER: MODEL 8709, LOT# N064786028| EXPLANTED: