BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3241142 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12105
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S INCISION WAS SWOLLEN AND TENDER TO THE TOUCH. THE PATIENT WAS ON THE WAY TO THE HOSPITAL. THE PUMP WAS DELIVERING BACLOFEN. IT WAS LATER REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITE. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) ON (B)(6) 2013. THE STITCHES WERE REMOVED ABOUT ONE WEEK AFTER IMPLANT. THERE WERE 2 STITCHES FOUND THAT HAD NOT BEEN REMOVED. THE INCISION SITE WAS CLEANED OUT. THERE HAD BEEN A "PUSS POCKET". AROUND THE "BELLY BUTTON" AREA THERE WAS A SCAB - THEY FOUND A STITCH THAT HAD NOT BEEN REMOVED. IT WAS "AN INSIDE STITCH THAT LEFT A PUSS POCKET. THE PUSS WAS "PUSHED OUT" AND THEY FOUND ANOTHER STITCH UNDERNEATH. THE STITCH WAS NEAR THE SPINAL CORD ON THE BACK SIDE. THE BACKSIDE WAS ¿PUFFY AND GOOSHY¿ A DYE STUDY WAS RECOMMENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE DATE OF ONSET/DIAGNOSIS OF THE INFECTION WAS (B)(6) 2013. THE PATIENT EXPERIENCED SWELLING, PAIN AND ¿BOGGINESS¿ UNDER THE INCISION. THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET AND THE LUMBAR REGION. THE PATIENT OUTCOME WAS ¿NO DRUG WITHDRAWAL.¿ IT WAS NOTED ¿THERE IS NOT AN INFECTION AT THIS TIME. BOGGINESS AND REDNESS WERE NOTED ALONG WITH A SCAB.¿ THE DATE OF LAST REFILL WAS (B)(6) 2013. THE PUMP WAS DELIVERING GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340575 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 MO Other| R