BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2210530 · Received August 10, 2011

    Report

    Report Number
    3007566237-2011-06237
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    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

    IT WAS REPORTED THAT THE PATIENT HAD A SEROMA. THE PATIENT WAS ABOUT TO BEGIN A SURGICAL REVISION PROCEDURE. THERE WAS FLUID BUILDUP IN POCKET AND IN BACK, AS WELL. ALSO, THE PUMP WAS UNABLE TO TELEMETRY AND MAY BE FLIPPED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED 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 Required Intervention