BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082980 · Received July 28, 2008

    Report

    Report Number
    2182207-2008-04434
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING LETHARGY. HE WAS TAKEN TO THE EMERGENCY ROOM AND GIVEN NARCAN. THE REPORT INDICATES THAT HE "WOKE RIGHT UP". DEVICE TROUBLESHOOTING WAS BEING CONSIDERED. THE MEDICATION USED IN THE PUMP WAS COMPOUNDED BACLOFEN. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 Required Intervention EXPLANTED| PROGRAMMER MODEL 8840 LOT#UNK| IMPLANTED| CATHETER MODEL 8703W LOT#L43278