BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2092136 · Received April 27, 2011

    Report

    Report Number
    3007566237-2011-03116
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    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

    AT THE PUMP REFILL, THE ACTUAL RESIDUAL VOLUME (28 ML) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (2 ML). THERE WERE NO PUMP ALARMS. THE PROGRAMMING WAS REPORTED TO BE CORRECT. IT WAS NOTED THAT THE PATIENT HAD BEEN SEEN 3 TIMES DURING THE REFILL CYCLE FOR DOSING INCREASES. 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 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1