BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1994352 · Received January 14, 2011

    Report

    Report Number
    3007566237-2011-00372
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS COMING OUT OF BACK "WHERE CAN MASH THE CATHETER." A DYE STUDY WAS PERFORMED IN JUNE OR JULY; RESULTS WERE NOT PROVIDED. IT WAS HARD AROUND THE CATHETER. THE PT WAS HEARING THE PUMP BEEP INTERMITTENTLY. THE PHYSICIAN WAS UNABLE TO HEAR ANY BEEP. IT WAS NOTED THAT THE PRINT OUTS DO NOT SHOW THE PUMP GOING OFF. THE PT HAS REQUESTED THAT THE PUMP BE REPLACED INDICATING THAT IT WORKED IN THE BEGINNING AND NOW IT DOESN'T. THE PUMP WAS USED TO DELIVER DILAUDID 9.14 MG/DAY. PER THE REPORTER, THE DOSE WAS BEING ADJUSTED EVERY MONTH AND NOW IT HAS NOT BEEN RAISED SINCE JUNE OR JULY. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR IMPLANTED:| CATHETER: MODEL 8709, LOT# N077824026| EXPLANTED: