BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2172594 · Received July 20, 2011

    Report

    Report Number
    3007566237-2011-05606
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HAD A BACLOFEN PUMP FOR (B)(6). THE PUMP HAD RECENTLY RUN DRY BECAUSE IT WAS GOING TO REACH EOL. THE REPORTER CONCERNED THAT THE CATHETER WAS NOT WORKING PROPERLY BECAUSE THE PT WAS RECEIVING 620MCG/DAY, WHICH IS ABOVE THE AVERAGE OF 320. WHEN THE PT'S HEALTH CARE PROVIDER WENT TO EXPLORE THE CATHETER, IT WAS DISCOVERED THAT PART OF IT WAS "SHEERED," SO THE PT'S HEALTH CARE PROVIDER REPLACED THE ENTIRE DEVICE, INCLUDING THE PUMP. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS BACLOFEN. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709, LOT# J11599R60| IMPLANTED: