BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143019 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04721
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 26, 2011
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011 THAT A PT EXPERIENCED PAIN WHEN WALKING. THE PT EXPERIENCED INCREASED SPASMS AND NECK PAIN WHILE WALKING. BACLOFEN AT A CONCENTRATION OF 250 MCG/ML WAS USED IN THE PUMP AT A DOSE OF 80 MCG/DAY, WHICH WAS INCREASED OVER THE PREVIOUS DOSE OF 70.03 MCG/DAY. THE CATHETER WAS REPLACED ON (B)(6) 2011 AND FOUND TO BE FRACTURED. EVENT SEVERITY WAS REPORTED AS MODERATE. THE PT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE. ADD'L INFO HAS BEEN REQUESTED AND WILL BE REPORTED IF IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention CATHETER: MODEL 8711, LOT# N102628008| EXPLANTED:| IMPLANTED: