BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3200951 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02174
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOT OF PROBLEMS WITH THE PUMPS. THE PATIENT WAS VERY TINY. SEVERAL TIMES, THE PUMPS MIGRATED AND NEEDED TO BE REPOSITIONED OR REMOVED. THE PATIENT HAD ¿A GOOD 25 SURGERIES¿. THE PATIENT STATED THAT IN SPITE OF THE PROBLEMS, THE PUMP HELPED HER; IT WORKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303103 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention