BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2861352 · Received December 7, 2012

    Report

    Report Number
    6000030-2012-00215
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # L62218, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS PUMP FAILURE. THE PATIENT WAS "A LITTLE CONFUSED." THERE WAS A MAGNETIC RESONANCE IMAGING/X-RAY/COMPUTATIONAL TOMOGRAPHY SCAN DONE IN (B)(6) 2012 AND THE RESULT WAS "WITHIN NORMAL LIMITS." THE PATIENT WAS EXPERIENCING PAIN AND HAD PROBLEMS REMEMBERING. THE PATIENT OUTCOME WAS NOTED AS ONGOING SERIOUS INJURY OR ILLNESS.

    Description of Event or Problem · 1

    THE PATIENT CAME TO THE ER ON (B)(6) 2012 AND WAS NOTED TO BE A "LITTLE LETHARGIC." THE PATIENT WAS ALSO EXPERIENCING HEADACHES AND SHORT TERM MEMORY LOSS. SHE INITIALLY WENT TO A PAIN CLINIC, BUT THEY SENT HER TO THE ER. THE PUMP WAS INTERROGATED AND SHOWED A SIMPLE CONTINUOUS INFUSION OF DILAUDID AT 7MG/DAY. THE PUMP WAS ALSO NOTED TO BE PAST ITS EXPECTED LIFE SPAN AND SHOWED A LOW BATTERY ALARM IN EFFECT SINCE (B)(6) 2012; THE ALARM HAD BEEN DISABLED. THE ER PHYSICIAN ORDERED THE PUMP BE DECREASED TO THE MINIMUM RATE WHILE CONTINUING THE SIMPLE CONTINUOUS INFUSION. THE PUMP WAS UPDATED TO A RATE OF 0.5 MG/DAY PER THE ER PHYSICIAN'S ORDER. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE ER PHYSICIAN STATED THAT HE WOULD DISCUSS WITH PATIENT'S PUMP MANAGING PHYSICIAN. ON (B)(6) 2012, IT WAS REPORTED THAT THE PHYSICIAN HAD STOPPED THE PATIENT'S PUMP AND WAS CONSIDERING DOING AN MRI. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization