BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201399 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00144
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 14, 2012
    Report Date
    February 29, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 8731SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER RECEIVING AN IMPLANTABLE DRUG PUMP THE PATIENT EXPERIENCED HEADACHES. IT WAS SURMISED THAT THEY HAD ¿AN ADDITIONAL LUMBAR PUNCTURE¿ IN TRYING TO GET THE CATHETER IN. A BLOOD PATCH WAS DONE. THE HEADACHE RESOLVED, BUT THEN WHEN THE PATIENT STOOD OR LAID DOWN THE PATIENT EXPERIENCED PAIN GOING DOWN THE BACK OF BOTH LEGS. THIS NEW PAIN PROGRESSED OVER THE COURSE OF THE LAST FEW DAYS. THE DRUG IN THE PUMP WAS BUPIVACAINE. ADDITIONAL INFORMATION STATED THAT THE PATIENT¿S SYMPTOMS RESOLVED ON THEIR OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303296 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention