BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032467 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02315
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    January 1, 2010
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AT TWO PRIOR REFILLS, THE EXPECTED RESIDUAL VOLUME WAS 3ML AND THE ACTUAL RESIDUAL VOLUME WAS 6ML. THE MOST RECENT EXPECTED RESIDUAL VOLUME WAS 2.8ML AND THE ACTUAL RESIDUAL VOLUME WAS 7ML. THE BACLOFEN DOES NOT INCREASED SLIGHTLY WITH NO RESPONSE. PER THE REPORTER, THERE WERE NO CHANGES IN SYMPTOMS AND NO ACTIVE SIGNS OR SYMPTOMS OF BACLOFEN WITHDRAWAL; HOWEVER, THE PT DID HAVE INCREASED SPASTICITY. IT WAS UNK IF THAT WAS NORMAL PROGRESSION OF THE HEREDITARY SPASTIC HEMIPLEGIA OR AN ISSUE WITH THE PUMP. THE LOGS WERE NEGATIVE. THE PUMP WAS REPLACED AND FILLED WITH LIORESAL. THE PUMP DOSE WAS BEING ADJUSTED EVERY 10-14 DAYS. SINCE THE REPLACEMENT, THE PT WAS DOING GREAT.

    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 50 YR Required Intervention CATHETER: MODEL 8709, LOT# J12365R25| IMPLANTED:| EXPLANTED: