BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2994288 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03480
    Event Type
    Death
    Date Received
    March 8, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT¿S SPINE WAS BRUISED DURING PUMP IMPLANT IN (B)(6) 2013 WHICH CAUSED HIM "ALL KINDS OF PROBLEMS". THEN HE DEVELOPED ¿A LOT OF OTHER THINGS AFTER THAT¿. THE REPORTER WAS UNSURE IF THE PUMP WAS EVER REACTIVATED; THE PATIENT ¿NEVER GOT TO THE POINT WHERE HE COULD HAVE USED IT¿. THE PATIENT EXPIRED. ADDITIONAL INFORMATION: THE PUMP MANAGING PHYSICIAN¿S OFFICE WAS UNAWARE THAT THE PATIENT HAD PASSED AWAY. THE PATIENT¿S CAUSE OF DEATH WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT¿S DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT HAD THEIR SYSTEM IMPLANTED ON (B)(6) 2013. THE PATIENT LEFT THE DOCTOR'S OFFICE THAT DAY WITH A LOT OF PAIN. ONCE AT HOME, THE PATIENT USED A WALKER TO ASSIST TO THE BATHROOM, SAT DOWN, AND COULD NOT STAND. THE PATIENT REPORTED "ELECTRICITY SHOOTING DOWN" BOTH LEGS AND NUMBNESS IN THE RIGHT LEG. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL ON (B)(6) 2013. IT WAS ORIGINALLY THOUGHT THAT THE PATIENT HAD INFLAMMATION. THE PATIENT ALSO HAD DIFFICULTY VOIDING AND A URINARY CATHETER WAS PLACED WITH SUCCESSFUL VOID. THIS PATIENT WAS REPORTED TO HAVE ONE KIDNEY. EXCRUCIATING PAIN AND TINGLING CONTINUED IN THE PATIENT'S LEGS. IN ADDITION, THE RIGHT LEG, WHICH WAS THE PATIENT'S "BEST LEG," WAS THEN VERY NUMB AND WEAK, "LIKE DROP FOOT." AS THE PATIENT HAD "A LOT OF HEALTH PROBLEMS," WARRANTED FURTHER TESTING AND POSSIBLE A PUMP EXPLANT THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. IT WAS UNKNOWN WHAT CAUSED THE PATIENT'S SYMPTOMS. IT WAS ALSO REPORTED THAT THE PUMP HAD NOT "CAUSED THE PROBLEM." THE PUMP WAS REPROGRAMMED DUE TO THE PATIENT'S SYMPTOMS BUT IT WAS UNCLEAR INITIALLY WHETHER IT WAS TURNED OFF OR STOPPED. ONE REPORTER STATED ALARMS WERE NOT HEARD. THE PATIENT WAS REPORTED TO HAVE HAD "ALL KINDS OF TESTS" INCLUDING A MAGNETIC RESONANCE IMAGING (MRI) SCAN. IT WAS THEN REPORTED THAT IT WAS THOUGHT THE PUMP DID NOT NEED TO BE EXPLANTED; FROM THE REPORTED TESTS DONE "THEY DON'T THINK THE PUMP IS REALLY DOING ANYTHING." IT WAS THEN SUSPECTED THAT THE PATIENT'S "SPINE WAS BRUISED" WHEN THE SYSTEM WAS IMPLANTED AND THE PATIENT WOULD COMPLETE TWO WEEKS OF PHYSICAL THERAPY. THE PATIENT WAS LATER ABLE TO STAND AND WALK. FURTHER, THIS PATIENT WAS LATER SEEN BY A PHYSICIAN'S ASSISTANT AND IT WAS CONFIRMED THAT THE PUMP WAS PROGRAMMED AS STOPPED AND HAD NOT BEEN PROGRAMMED OFF. THIS DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. 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
    99464 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Death| H| R