BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061966 · Received April 5, 2011

    Report

    Report Number
    3007566237-2011-02608
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 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

    THE ACTUAL RESIDUAL VOLUME (19 ML) WAS GREATER THAN THE EXPECTED VOLUME (5.8 ML). THERE WAS NO PUMP ALARMS. IT WAS THOUGHT THAT A CATHETER OCCLUSION MIGHT BE THE CAUSE OF THE PROBLEM. 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR PROGRAMMER: MODEL 8835, LOT# NPG020822N| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N274706014| EXPLANTED:| EXPLANTED:| IMPLANTED: