BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3233695 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11962
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 24, 2013
    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 PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED EROSION AT THE POCKET SITE OCCURRED AS WELL AS AN INFECTION. DRAINAGE/INCISION WOUND OPENING WAS OBSERVED AT THE PUMP POCKET. THE PATIENT ALSO EXPERIENCED PAIN. A POCKET REVISION TOOK PLACE ON (B)(6) 2013. INTRAOPERATIVELY, ANTIBIOTICS WERE GIVEN TO THE PATIENT AND A CULTURE OF THE DEVICE POCKET WAS TAKEN. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN AND DILAUDID. IT WAS LATER REPORTED THE CULTURES TAKEN INTRAOPERATIVELY WERE NEGATIVE FOR AN INFECTION. THE PATIENT CAME INTO THEIR HEALTH CARE PROVIDER¿S OFFICE ON (B)(6) 2013 WHICH TIME 43ML OF BLOOD-TINGED FLUID WAS ASPIRATED FROM THE POCKET. THERE WAS NO EVIDENCE OF PUS AND THE PATIENT WAS AFEBRILE. THE DIAGNOSIS WAS A SEROMA AT THE PUMP SITE WITHOUT INFECTION. THE PLAN WAS TO CONTINUE TO MONITOR THE PATIENT. IT WAS REPORTED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334956 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention