BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3030556 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04467
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 5, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THE ENTIRE SYSTEM REMOVED AT THE END OF FEBRUARY BECAUSE THE HEALTHCARE PROVIDER (HCP) WAS CONCERNED THE PATIENT WOULD GET INFECTION IN THE SPINE. THE DATE OF ONSET OR DIAGNOSIS OF INFECTION WAS (B)(6) 2013. THE PATIENT INDICATED THAT IT WAS LATER FOUND THAT THE INFECTION WAS "NOT EVEN FROM THE PUMP", AS HE HAD PULLED HIS TEETH OUT AT THE SAME TIME PERIOD AS THE PUMP IMPLANT AND BELIEVED THAT TO BE THE CAUSE OF THE ISSUES. THE PATIENT'S SYMPTOMS WERE FEVER, REDNESS, SWELLING AND PAIN OF THE DEVICE POCKET. THERE WERE CULTURES DONE OF THE DEVICE POCKET, LUMBAR REGION AND BLOOD WITH NO GROWTH. IT WAS NOTED THE PATIENT HAD BEEN ON ANTIBIOTICS PRIOR TO THE CULTURE BEING OBTAINED HOWEVER. THE TREATMENTS FOR THE INFECTION WERE BOTH IV AND ORAL ANTIBIOTICS, WHICH INCLUDED PERIOPERATIVE ANTIBIOTICS, AND TOTAL SYSTEM EXPLANT. THE PATIENT DESIRED TO HAVE THE PUMP RE-IMPLANTED, AS HE DID NOT HAVE PAIN WHEN HE DID HAVE THE PUMP, BUT THE PATIENT NOTED WANTING A NEW HCP TO IMPLANT THE NEXT PUMP. THE PATIENT'S OUTCOME WAS REPORTED AS INFECTION RESOLVED WITH NO DRUG WITHDRAWAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AT THE TIME OF REPORT, THE PATIENT WAS FIGHTING AN INFECTION WHICH BEGAN ABOUT THREE WEEKS AFTER IMPLANT. AT THAT TIME, THE PATIENT WENT TO THE HOSPITAL WHERE CULTURES WERE TAKEN, BUT NO ORGANISMS GREW. THE NEXT MORNING, THE HEALTHCARE PROVIDER HAD PLANNED TO EXPLANT THE PUMP, BUT THE PATIENT REFUSED THE SURGERY. THE PATIENT SOUGHT AN INFECTIOUS DISEASE DOCTOR WHO THEN PRESCRIBED INTRAVENOUS ANTIBIOTICS FOR HOME-USE UNTIL THE INFECTION CLEARED. IT WAS STATED THAT THE PATIENT'S 'BLOOD WORK,' FROM THE FRIDAY PRIOR TO REPORT, CAME BACK 'CLEAR.' IT WAS ALSO NOTED THAT THE DOCTOR WASN'T SURE IF THE EVENT 'COULD BE SOMETHING ELSE,' SO THE PATIENT WAS TO BE KEPT ON THE ANTIBIOTICS FOR A WHILE. THE DRUG USED IN THIS SYSTEM WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134904 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention