BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063781 · Received April 15, 2011

    Report

    Report Number
    3007566237-2011-02845
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 1, 2008
    Report Date
    April 2, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED INCREASED BASELINE SPASTICITY. PUMP VOLUMES WERE CHECKED AND MEASURED EQUALLY. AN MRI OF THE PATIENT'S NECK AND BACK SHOWED NO ISSUES AND A RENAL ULTRASOUND SHOWED NO ISSUE. A CATHETER DYE STUDY WAS DONE. FOLLOWING THE DYE STUDY, THE PATIENT EXPERIENCED OVERDOSE SYMPTOMS. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT NO LONGER HAD THE DEVICES IMPLANTED.

    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 50 YR Other IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| EXPLANTED:| CATHETER: MODEL 8709, LOT# L81594| EXPLANTED:| IMPLANTED: