BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4781903 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-09376
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DOES NOT APPLY AND WAS REMOVED. (B)(4)..

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY NEEDED A NEW DOCTOR, AND THAT TWO HEALTHCARE PROVIDERS (HCP) WOULD NOT SEE THEM BECAUSE THEIR ¿DOSE WAS TOO HIGH¿. THEY STATED THAT ALL THEY WERE TOLD WAS ¿THEY WERE GETTING 10 MG A DAY, AND THAT WAS TOO HIGH¿. THEIR BACK HAD BEEN HURTING A LOT MORE IN THE PAST COUPLE OF WEEKS ON THE RIGHT SIDE, AND THAT WAS WHERE THE PUMP WAS. THEY STATED THAT IT HURT REALLY BAD WHEN STANDING AND WALKING, AND EVERY NOW AND THEN THEY HAD A STABBING PAIN. THEY STATED THAT THEY THOUGHT ¿SOMETHING WAS WRONG WITH THE PUMP¿, AND IT WAS MAKING A FUNNY NOISE THAT SOUNDED LIKE A SIREN. THEY STATED IT WAS THE CRITICAL ALARM, AND THIS BEGAN ON (B)(6) 2015. AS OF (B)(6) 2015 THE PATIENT FOUND A SURGEON TO REPLACE THE PUMP, BUT THEY HAD TO BE OFF ALL PAIN MEDICATIONS BEFORE THEY WOULD DO IT. THE PATIENT WAS TO BE OFF ALL OF THEM BY THE UPCOMING WEEKEND. THE PATIENT WAS TOLD BY THEIR HCP THAT THE PUMP MALFUNCTIONED, AND IT WAS NOT PUMPING AT ALL. THE PUMP WAS REPORTEDLY NOT EMPTY, AND IT CONTAINED BUPIVACAINE AND DILAUDID.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S PUMP WAS REPLACED (B)(6) 2015.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT TELEMETRY CONFIRMED THE CRITICAL ALARM HEARD WAS DUE TO A MOTOR STALL. THE PUMP HAD BEEN ALARMING FOR "QUITE SOME TIME." THE PUMP WAS TURNED OFF WITH PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326332 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention