BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1132633 · Received August 22, 2008

    Report

    Report Number
    2182207-2008-05186
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 27, 2008
    Report Date
    July 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT A WEEK AFTER IMPLANT THE PT DEVELOPED A HIGH FEVER. IT WAS ALSO REPORTED THAT THE PT WENT FROM WALKING ON HER OWN TO NOT GETTING OUT OF BED. NO PT TREATMENT OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. NO FURTHER F/U WAS POSSIBLE AS NOT PT OR DEVICE IDENTIFIERS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| PROGRAMMER MODEL UNK LOT # UNK| EXPLANTED| CATHETER MODEL UNK LOT# UNK