BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1192063 · Received October 7, 2008

    Report

    Report Number
    2182207-2008-06382
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 12, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSP WITH INCREASED SPASTICITY. THE PT DID NOT HAVE A FEVER. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING. THE PUMP WAS FOUND TO BE IN SAFE STATE WITH LOW BATTERY INDICATED IN THE EVENT LOGS. THE PT WAS GIVEN BENZODIAZEPINES AND THE PUMP WAS REPROGRAMMED AND UPDATED WITH A THERAPEUTIC BOLUS DOSE. THE PT RESPONDED. THE PT WAS DISCHARGED TO HOME WITH THE PUMP PROGRAMMED TO THE PRIOR THERAPEUTIC SETTINGS. THE PATIENT'S SPASTICITY WAS WELL MANAGED. THE PHYSICIAN WAS AWARE THAT THE PUMP MAY RESET TO SAFE MODE. THE PATIENT'S FAMILY WAS EDUCATED TO RETURN IF SYMPTOM CONTROL DECLINED AGAIN. IT WAS UNCLEAR IF THE PUMP RESET TO SAFE STATE AGAIN, BUT THE PUMP WAS REPLACED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 12 YR Hospitalization| R CATHETER MODEL 8711| EXPLANTED| PROGRAMMER MODEL 8840