BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1901954 · Received November 12, 2010

    Report

    Report Number
    3007566237-2010-09420
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, MENINGITIS WAS RULED OUT. THE DOCTOR WANTED TO ASPIRATE THE CATHETER ACCESS PORT (CAP) FOR LABORATORY TESTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention CATHETER: MODEL 8709, LOT #N005269325| EXPLANTED:| IMPLANTED: