BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1902200 · Received November 15, 2010

    Report

    Report Number
    3007566237-2010-09523
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT TO THE HCP FOR AN INCREASE IN DAILY DOSE OF MEDICATION. THE PUMP WAS INTERROGATED, BUT THIS WAS NOT SUCCESSFUL. THE PUMP WAS INTERROGATED AGAIN IN A DIFFERENT ROOM IN CASE OF ELECTROMAGNETIC INTERFERENCE, BUT THIS WAS ALSO UNSUCCESSFUL. THE HCP LISTENED TO THE PUMP WITH A STETHOSCOPE TO SEE IF A "TICKING SOUND" COULD BE HEARD, BUT THIS TEST WAS NEGATIVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. AT THE HOSPITAL, THE PUMP WAS UNSUCCESSFULLY INTERROGATED AGAIN. TWO X-RAYS WERE TAKEN WITH AN INTERVAL OF 3 HOURS IN ORDER TO SEE IF THE ROTOR HAD MOVED. THE RESULTS WERE UNKNOWN. THE PATIENT DID NOT HAVE SYMPTOMS OF WITHDRAWAL, "JUST A MILD FEVER SOMETIMES DURING THE DAY AND PERIODS OF SHIVERING AND FEELING COLD." THE MILD FEVER STARTED ON (B)(6)2010. THE PUMP WAS REPLACED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS BACLOFEN.

    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 4 YR Hospitalization| R