BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1181215 · Received September 30, 2008

    Report

    Report Number
    2182207-2008-06236
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL REPORTED AN INFECTION. THE PUMP WAS USED TO DELIVER BACLOFEN. FOLLOW-UP WAS DONE WITH THE INITIAL REPORTER WHO STATED THAT SHE WAS FROM A DRUG INFORMATION CENTER AND WAS WORKING AS AN INTERMEDIARY WITH A HOSPITAL PHARMACIST DISCUSSING INTRATHECAL TO ORAL CONVERSION OF MEDICATION. THE PATIENT AND DEVICE INFORMATION WAS NOT PROVIDED TO THE DRUG INFORMATION CENTER. FURTHER FOLLOW-UP IS NOT POSSIBLE DUE TO THE LACK OF PATIENT AND DEVICE INFORMATION.

    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 CATHETER MODEL CATHETER LOT # UNKNOWN IMPLANTED| EXPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNKNOWN| EXPLANTED