BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1940799 · Received December 23, 2010

    Report

    Report Number
    3007566237-2010-10720
    Event Type
    Injury
    Date Received
    December 23, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING SOME SORT OF A CATHETER DYE STUDY AND HAD AN EVENT; NO ADDITIONAL DETAILS WERE PROVIDED REGARDING "THE EVENT" OR THE REASON FOR THE DYE STUDY. SOON THEREAFTER, THE PT WAS FOUND TO HAVE MENINGITIS. THE PUMP WAS EXPLANTED. THE PT WAS TREATED AND HAD SINCE GONE TO A REHABILITATION HOSPITAL BECAUSE HE HAD BEEN STRUGGLING WITH SPASTICITY; NOT WITHDRAWAL, BUT DIFFICULTY CONTROLLING HIS SPASTICITY. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8709SC, LOT #: N224961015| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT #: UNK