BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1983068 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00886
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF VERTEBRAL BODY HEIGHT IN THE THORACOLUMBAR AREA DUE TO INCREASED KYPHOSIS. THIS RESULTED IN A VERY UNCOMFORTABLE "SITTING" POSITION OF THE PUMP FOR THE PT. THE PUMP WAS SURGICALLY REPOSITIONED ON (B)(6) 2011. THE PT OUTCOME WAS RESOLVED WITHOUT SEQUELAE. THE PUMP DELIVERED DILAUDID AND DROPERIDOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N090990025