BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1953846 · Received January 4, 2011

    Report

    Report Number
    3004209178-2011-00026
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THREE WEEKS AGO, THE PT FELL AND BROKE HER HIP; SHE HAD SURGERY TO REPAIR HER HIP. THE PAST WEEK, THE PT HAD BEEN "BLACKING OUT" BETWEEN 10:30 AND LUNCH, AFTER HER PHYSICAL THERAPY. THE DEVICE SYS WAS USED TO DELIVER FENTANYL. 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J12342R10