BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1080194 · Received July 22, 2008

    Report

    Report Number
    2182207-2008-04227
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    January 30, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PATIENT HAD A "BEEFY RED BOIL" WAS OBSERVED 6 CM ABOVE THE PUMP SITE, NEAR THE POCKET OF THE INTRATHECAL PUMP. THE PATIENT HAD AN INFECTION. THE PUMP AND CATHETER WERE EXPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN| EXPLANTED:| CATHETER MODEL 8709 LOT# N068117017