BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2082973 · Received May 4, 2011

    Report

    Report Number
    3007566237-2011-03238
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 11, 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 PT HAD AN INFECTION. REPORTEDLY, THE PUMP "IS GOING TO BE EXPLANTED." INFO REGARDING "PUMP OFF STATE" WAS REVIEWED. THE DRUG CONTAINED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. LACK OF PT IDENTIFIERS PREVENTS FURTHER FOLLOW-UP FOR ADDITIONAL INFO.

    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