BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2864158 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11363
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CEREBRAL SPINAL FLUID (CSF) LEAK ON (B)(6) 2012. IT WAS REPORTED ON (B)(6) 2012 THAT THE PATIENT HAD A HEADACHE AND ON (B)(6) 2012 ABDOMINAL EDEMA WAS NOTED AT THE INCISION SITE. INTERVENTION INCLUDED AN ABDOMINAL BINDER ON (B)(6) 2012, FOLLOWED BY A SEROMA DRAIN AND BLOOD PATCH ON (B)(6) 2012. IT WAS INDICATED THAT THE CSF WAS CULTURED ON (B)(6) 2012 AND THERE WAS NO GROWTH AFTER 4 DAYS. THERE ALSO WAS A CATHETER DYE STUDY PERFORMED ON THAT SAME DAY AND RESULTS REVEALED A PERSISTENT LEAK ALONG PREVIOUS CATHETER TRACT SITE. IT WAS LATER REPORTED OF RECURRENT FLUID COLLECTION ON (B)(6) 2012. IT WAS NOTED ON (B)(6) 2012 THAT ANOTHER CAP STUDY WAS DONE TO CHECK POST CSF REPAIR AND FOUND NO LEAK IN THE CATHETER. THE OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2012. THE DRUG DELIVERED VIA PUMP WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention