BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3082500 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07003
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS ¿FOR PROGRAMMING ONLY¿. ON (B)(6) 2013 A "PUMP PROGRAMMING FLUOROSCOPY" WAS PERFORMED AND NOTED NORMAL FUNCTION. THE PATIENT HAD EXPERIENCED BACK PAIN. THE PATIENT OUTCOME WAS ¿NO INJURY¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERDOSE. THE PATIENT WAS IN FOR A REFILL ON (B)(6) 2013 AND THERE WAS NOTHING UNUSUAL ABOUT THE REFILL. ABOUT 5-6 MIN AFTER THE REFILL THE PATIENT GOT SLEEPY, STOPPED BREATHING AND HAD TO BE PUT ON A VENTILATOR. ONCE THE PATIENT WAS STABILIZED THE HCP PULLED THE FULL 20ML OUT OF THE PUMP. IT WAS NOTED THAT THE HCP HAD DIFFICULTY PUSHING THE NEEDLE IN AND PULLING IT OUT DUE TO SCAR TISSUE. A DYE STUDY WAS BEING PLANNED TO CONFIRM THAT THE CATHETER WAS NOT PUNCTURED DURING THE REFILL. IT WAS REPORTED THAT THE PATIENT ACTED LIKE THEY RECEIVED A HUGE BOLUS OF DRUG. THE PATIENT HAD TAKEN 20 MG OF VALIUM BEFORE THE REFILL AND HAD ALSO GIVEN HIMSELF A PTM BOLUS BEFORE THE REFILL. IT WAS ALSO NOTED THAT THE PATIENT HAD ALCOHOL THE NIGHT BEFORE. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL, BUPIVACAINE AND COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183660 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R