BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1082628 · Received July 25, 2008

    Report

    Report Number
    2182207-2008-04411
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP AND CATHETER WERE EXPLANTED DUE TO INFECTION. THE PT WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS. THE PUMP CONTAINED LIORESAL. THE PT RECOVERED WITHOUT SEQUELA. 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 LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709 LOT# L6477| IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED: