BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRHOMED II

    MDR report key: 1220424 · Received November 4, 2008

    Report

    Report Number
    2182207-2008-07166
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, SHAKING, AND SWEATING FOR 3-4 DAYS. THE PATIENT VISITED THE HOSPITAL 3 TIMES. THE LAST TIME THE PATIENT WAS ADMITTED TO THE HOSPITAL. IT WAS UNKNOWN WHEN THE PATIENT'S NEXT REFILL WAS SCHEDULED OR WHAT MEDICATION WAS IN THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| IMPLANTED:| EXPLANTED: