BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1910481 · Received November 18, 2010

    Report

    Report Number
    3007566237-2010-09781
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A PUMP REFILL SESSION, THE PT EXPERIENCED UNDERDOSE SYNDROMES OF INCREASED TONE AND SHAKING. THE HCP BELIEVED A POCKET FILL LIKELY OCCURRED SINCE THE RESERVOIR WAS EMPTY WHEN IT WAS ASPIRATED ON (B)(6) 2010. THE HCP WAS ABLE TO ASPIRATE THE RESERVOIR, BUT UNABLE TO FILL IT. THE HCP ASPIRATED SYRINGE FULLS OF AIR AND THEN CHANGED SYRINGES AND WAS ABLE TO FILL THE PUMP TO CAPACITY. THE HCP PROGRAMMED A 40 MCG BOLUS TO ADDRESS UNDERDOSE SYMPTOMS.

    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 11 YR Required Intervention CATHETER: MODEL 8709, LOT# J12385R04| IMPLANTED:| EXPLANTED: