BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2073585 · Received April 27, 2011

    Report

    Report Number
    3007566237-2011-03155
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    December 6, 2010
    Report Date
    April 12, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    K860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED "BLOOD CLOTS AND HEAD BLEEDING" WHICH WERE A "CONSEQUENCE" OF THE PT'S "OLDER" PUMP. THE PUMP WAS REPLACED; ALL WAS "GOING WELL" FOR THE PT. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8711, LOT# N098653005| EXPLANTED: