BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3588227 · Received January 22, 2014

    Report

    Report Number
    3004209178-2014-01006
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Report Date
    January 6, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ¿KNEW¿ THE CATHETER ¿CAME OUT¿ ON THE (B)(6). THE PATIENT REPORTEDLY COULD NOT LIFT HER FEET OFF THE FLOOR, HER LEGS WERE ¿ON FIRE, EVERYTHING WAS BURNING,¿ SHE COULD NOT SIT STILL AND WAS CRYING. THE PATIENT STATED, SHE WAS AT HER SHORE HOUSE AT THE TIME AND HER SPOUSE BROUGHT HER HOME AND ¿THEY SAID THE TUBE CAME OUT.¿ THE PATIENT WAS NOT HAPPY AND DISSATISFIED WITH HER CURRENT PHYSICIAN AND WAS SEEKING ANOTHER. THE PATIENT WAS PUT BACK ON PILLS AND THE PATIENT AND HEALTH CARE PROVIDER HAD BEEN ¿ARGUING¿ ABOUT WHAT TO DO. REPORTEDLY, THE PHYSICIAN WANTED TO ¿DO IT RIGHT AWAY¿ AND THEN THOUGHT IT WAS NOT SAFE AND NOW HE WAS NOT SURE. THE PATIENT WAS ¿TIRED OF THE CRAP¿ AND STATED ¿THIS THING NEEDS TO COME OUT¿ OR SHE NEEDED TO FIND A PHYSICIAN THAT WAS WILLING TO ¿FIX AND MAINTAIN IT.¿ THE PATIENT COMMUNICATED WITH THE PHYSICIAN THAT THE TUBE WAS GIVING HER INCREDIBLE BACKACHES AND THE PHYSICIAN ¿DOES NOT WANT TO DO ANYTHING ABOUT IT.¿ IN ADDITION, IT WAS REPORTED THAT THE PHYSICIAN WAS NOT HAPPY THAT HE HAD TO CONTINUE TO DO PAIN MANAGEMENT AGAIN WHEN THE PATIENT WAS TO HAVE THE PUMP. THE PATIENT STATED, THE PHYSICIAN WANTED TO TRY A ¿RISKY WAY¿ TO SECURE IT BUT SHE DID NOT WANT THE PHYSICIAN TO TRY ¿NEW THINGS ON ME, I AM NOT A GUINEA PIG.¿ THIS DEVICE SYSTEM DELIVERED MORPHINE AT THE TIME OF THE EVENT. HOWEVER, SINCE THE CATHETER WAS NO LONGER SITTING IN HER SPINAL CORD, THE PUMP HAD BEEN TURNED DOWN TO THE LOWEST POSSIBLE SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52168 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR