BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3051386 · Received April 10, 2013

    Report

    Report Number
    3007566237-2013-01205
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 8709SC, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE EVENT WAS BELIEVED TO BE DUE TO A CEREBROSPINAL FLUID (CSF) COLLECTION. THE HEALTHCARE PROVIDER (HCP) STATED THERE WAS A PROBABLE CSF HYGROMA THAT SEEMED TO BE RESOLVING. THE PATIENT HAD LOST 40 OR MORE POUNDS AND THE PUMP WAS MORE NOTICEABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FLUID BUILD-UP AROUND HER PUMP SINCE IMPLANT. THE SEROUS FLUID HAD BEEN DRAINED MANY TIMES, ALWAYS 2 OZ OR MORE. IT WAS STATED THAT THE FLUID WOULD PROMPTLY RETURN WITHIN THIRTY MINUTES. AT TIMES, IT WOULD RANDOMLY LOWER AND THEN INCREASE AROUND THE PUMP AGAIN. AT THOSE TIMES, SHE WOULD FEEL NAUSEOUS OR VERY WEAK. IT WAS KNOWN THAT THE FLUID WAS NOT SPINAL FLUID OR FROM A PUMP LEAK. IT WAS REPORTED THAT THE FLUID WAS BEING CREATED BY THE PATIENT'S BODY IN RESPONSE TO THE PUMP. IT WAS LATER REPORTED THAT, APPROXIMATELY ONE WEEK AFTER SURGERY, THE PATIENT'S STITCHES BURST OPEN BECAUSE OF THE FLUID ACCUMULATION AROUND THE PUMP. IT WAS STATED THAT HER BODY APPEARED TO BE REJECTING THE PUMP. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM AND HAD TO STAY IN THE HOSPITAL FOR A "LONG WHILE" UNTIL ANOTHER SURGERY COULD BE PERFORMED. THE PUMP WAS EXPLANTED AND REPLACED WITH A NEW PUMP. IT WAS STATED THAT THE FLUID STUCK OUT ABOUT FOUR INCHES OFF OF THE PUMP. IT HAD BEEN DRAINED APPROXIMATELY SEVEN TIMES. EACH TIME THE FLUID WAS DRAINED, THE PATIENT WOULD FEEL "REALLY SICK", BUT WOULD FEEL BETTER ONCE THE FLUID CAME BACK. DURING ONE INSTANCE, THE FLUID DRAINED OFF BY ITSELF AND THE PATIENT BECAME EXTREMELY WEAK, WAS THROWING UP, AND WAS HAVING DIFFICULTY CONTROLLING HER MOVEMENTS. ABOUT A DAY AND A HALF LATER, THE FLUID CAME BACK AND THE PATIENT FELT NORMAL AGAIN. IT WAS NOTED THAT THE PATIENT HAD ATTEMPTED TO WEAR A BINDER OF HER STOMACH, BUT THE FLUID RETURNED 45 MINUTES AFTER REMOVING IT. IT WAS NOTED THAT ONE POSSIBILITY WAS AN ALLERGIC REACTION WITH THE PUMP, AS THE PATIENT WAS "ALLERGIC TO A LOT OF THINGS". THE DEVICE SYSTEM WAS INFUSING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149788 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Hospitalization| R