BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1983048 · Received February 4, 2011

    Report

    Report Number
    3007566237-2011-00887
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S INTRATHECAL PUMP HAD BECOME LOOSE AND MOVEABLE. THERE WAS EXTREME PUMP MOBILITY WITHIN THE SUBCUTANEOUS TISSUE. IT WAS STATED THAT 3 OF THE 4 SUTURES WERE FOUND TO BE BROKEN. THE PT HAD THEIR PUMP REPOSITIONED ON (B)(6) 2011. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVACAINE AND HYDROMORPHONE. THE EVENT WAS "ON-GOING."

    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 67 YR Required Intervention CATHETER: MODEL 8709, LOT# J11166R43| EXPLANTED:| IMPLANTED: