BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1000117 · Received February 19, 2008

    Report

    Report Number
    2182207-2008-00797
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 12, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAD A HIGH FEVER, MUSCLE CONTRACTION, A DROP IN BLOOD PRESSURE AND WAS ADMITTED TO THE INTENSIVE CARE UNIT OF THE HOSPITAL. THE PATIENT WAS RECEIVING BACLOFEN VIA THE PUMP. THE PATIENT WAS ALSO RECEIVING ORAL BACLOFEN AND VALIUM. NO PUMP ALARMS HAD BEEN HEARD AND NO DEVICE TROUBLESHOOTING HAD BEEN DONE. THE PATIENT'S WIFE WAS ENCOURAGED TO CONTACT THE PATIENT'S MANAGING HCP, SO DIAGNOSTIC TESTS COULD BE RUN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 76 YR Hospitalization| R CATHETER MODEL 8731 LOT# N069783023| IMPLANTED:| PROGRAMMER MODEL 8840 LOT # UNK| EXPLANTED:| IMPLANTED:| EXPLANTED: