BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032505 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02263
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 10, 2011
    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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SINCE THE PUMP SYSTEM WAS IMPLANTED, THE PT EXPERIENCED SWELLING OVER THE PUMP LOCATION. IT WAS LATER REPORTED THE PT WAS DIAGNOSED ON (B)(6) 2011 WITH A CSF (CEREBROSPINAL FLUID) LEAK AND SPINAL HEADACHE. THE SWELLING "STARTED UNDER RIGHT BREAST TO THIGH IN FRONT." THE BACK SWELLING WAS "THE SIZE OF AN ORANGE." TWO REVISION SURGERIES WERE PERFORMED ON (B)(6) 2011 AND (B)(6) 2011 TO ALLEVIATE THE LEAK. AFTER THE SECOND SURGERY, THE PAIN WAS ALLEVIATED. THE PT WAS TAKING ORAL BACLOFEN 15 MG/DAY. THE PUMP CONTAINED LIORESAL 500 MCG/ML. THE PT OUTCOME WAS REPORTED "NON-SERIOUS INJURY/ILLNESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N276842003| EXPLANTED: