BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1747671 · Received July 2, 2010

    Report

    Report Number
    3007566237-2010-05193
    Event Type
    Injury
    Date Received
    July 2, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 4, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CPK 1000+ AND RHABDOMYOLYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED MENTAL STATUS CHANGES AND A SLIGHT INCREASE IN SPASTICITY. A DYE STUDY WAS ATTEMPTED AND FAILED DUE TO INABILITY TO ASPIRATE. THE PT WAS GIVEN ORAL BACLOFEN. THE PT ALSO HAD A URINARY TRACT INFECTION, HEMATURIA, HIGH CPK (1000+) AND WAS IN RHABDOMYOLYSIS. AN LP BOLUS WAS BEING CONSIDERED. THE HEALTHCARE PROVIDER INDICATED THAT THE PT MAY HAVE HAD AN MI; HOWEVER, THE SEQUENCE OF EVENTS WAS UNCLEAR. IT WAS ALSO REPORTED THAT THE PT CODED AND THE INFUSION MODE WAS PROGRAMMED TO STOPPED PUMP PER PHYSICIAN ORDER. INTRATHECAL BACLOFEN WITHDRAWAL WAS INITIALLY SUSPECTED HOWEVER, LATER IT WAS FELT THAT THE PT MAY HAVE OVERDOSED ON ORAL BACLOFEN. THE PT WAS TAKEN TO SURGERY. THE PHYSICIAN DECIDED TO CHANGE THE PUMP DESPITE SEEING A KINK IN THE CATHETER. THE KINK WAS REMOVED AND CSF WAS VISUALIZED. AS OF (B)(6) 2010, THE PT WAS BACK TO BASELINE AND DISCHARGED.

    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 43 YR Hospitalization| L| R CATHETER: MODEL 8709, LOT# J0056630R| EXPLANTED:| IMPLANTED: