BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3103224 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01563
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER, SERIAL # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING A SEVERE REACTION AND THEY NEEDED THE MEDICATION ASPIRATED FROM THE RESERVOIR IMMEDIATELY. HCP PLANNED TO USE A 22 GAUGE NON-CORING NEEDLE TO REMOVE THE MEDICATION FROM THE PUMP. THE PUMP WAS DELIVERING BACLOFEN. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203456 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention