BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1081331 · Received July 24, 2008

    Report

    Report Number
    2182207-2008-04352
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    LITERATURE: KRACH, LE ET AL. "SATISFACTION OF INDIVIDUALS TREATED LONG-TERM WITH CONTINUOUS INFUSION OF INTRATHECAL BACLOFEN BY IMPLANTED PROGRAMMABLE PUMP." PEDIATRIC REHABILITATION, 2006.9(3): 210-218. POST-OPERATIVE INFECTION AND EXPLANT WITH SUBSEQUENT REIMPLANTATION OCCURRED SIX TIMES.

    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 UNK Required Intervention EXPLANTED| CATHETER MODEL CATHETER LOT# UNKNOWN| IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| IMPLANTED