BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRHOMED II

    MDR report key: 1378430 · Received May 8, 2009

    Report

    Report Number
    2182207-2009-03305
    Event Type
    Injury
    Date Received
    May 8, 2009
    Date of Event
    February 19, 2009
    Report Date
    April 10, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD THE CATHETER REPLACED DUE TO LEAKS IN THE CATHETER. ONE OF THE LEAKS WAS AT THE CENTER OF THE BACK THAT CAUSED A "BIG RED CIRCLE". THE OTHER LEAK WAS IN THE SPINAL AREA. THE PT STATED, "THE TUBE WAS TANGLED UP IN THE SPINAL AREA". PLEASE SEE MFR REPORT #2182007-2009-03301. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| EXPLANTED: