BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061789 · Received March 30, 2011

    Report

    Report Number
    3007566237-2011-02412
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    October 26, 2010
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: CORROSION AND RESIDUE WAS SEEN ON BOTH SURFACES OF GEAR WHEEL 3. ALSO, THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1807 OHMS. MULTIPLE LOW BATTERY RESETS WAS SEEN IN THE SYSTEM EVENT LOG BOTH IN THE FIELD AND DURING ANALYSIS. THE PRIMARY FINDING WAS HIGH S2 BATTERY RESISTANCE.

    Description of Event or Problem · 1

    THE PUMP HAD A DAILY INFUSION RATE OF 0.138 MLS/DAY. THE PATIENT HEARD AN ALARM. HE HAD BEEN FEELING 'A BIT WEIRD.' THE PUMP WAS AT END OF SERVICE. IT WAS REPLACED. THE PATIENT WAS OK AFTER REPLACEMENT. THE PUMP WAS USED TO DELIVER MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR