BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1052659 · Received May 23, 2008

    Report

    Report Number
    3004209178-2008-02796
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S INTRATHECAL DRUG DELIVERY PUMP WAS REMOVED DUE TO INFECTION. THE DRUG USED IN THE PUMP IS BACLOFEN. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT#UNK| EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT#L57096