BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063770 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02835
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    August 11, 2010
    Report Date
    April 4, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S PUMP WAS REPLACED. THE PT EXPERIENCED A POST OPERATIVE DURAL TEAR. SHE HAD MUCH MORE SWELLING AT HER BACK THAN NORMAL AND HAD INCREASED TONE ASSOCIATED WITH THE EVENT. THE PUMP WAS USED TO DELIVER LIORESAL. SHE WAS TOLD THAT SHE "HAD A SPINAL LEAK AND SHE NEEDS TO LAY FLAT 24/7 FOR WEEKS OR MONTHS." SURGICAL REVISION WAS DONE TO CLOSE THE DURA. THE PT WAS HOSPITALIZED ASSOCIATED WITH THE EVENT. THE PT OUTCOME WAS "NO INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N258738002