BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1040056 · Received May 7, 2008

    Report

    Report Number
    6000030-2008-02445
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    January 1, 2007
    Report Date
    July 15, 2013
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0745-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR MANUFACTURED PRIOR TO SEPT 1999 PHYSICIAN COMMUNICATIONS (DATED AUGUST 2007). PUMP MOTOR STALL HAS NOT BEEN CONFIRMED IN THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD MEMORY LOSS THAT HAD GOTTEN INCREASINGLY WORSE OVER THE PAST YEAR. AN UNDER DOSE WAS ALSO REPORTED; SYMPTOMS INCLUDED A RETURN OF SYMPTOMS AND DIZZINESS. THE PT HAD BEEN IN AND OUT OF HOSPITALS DUE TO HER SYMPTOMS. THE PT ALSO HAD A LUMP ON HER LOWER SPINE THAT APPEARS AND DISAPPEARS. THE PT WAS AT HOME AND HER STATUS WAS REPORTED AS 'FAIR. THE PUMP WAS FILLED WITH MORPHINE WHEN FIRST IMPLANTED, BUT THE MEDICATION HAD BEEN CHANGED TO DILAUDID. PUMP REFILL WAS NOT DUE FOR A MONTH. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT HAD A HORRIBLE EXPERIENCE WITH THE PUMP. ALL TYPES OF TESTS WERE DONE, INCLUDING A DYE STUDY. THE PUMP AND CATHETER WERE REPLACED. THE PUMP BATTERY NEEDED TO BE REPLACED AND THE CATHETER WAS REPLACED BECAUSE THE PHYSICIAN FOUND ¿PLASTIC TUBING DISCONNECTED AND KINKED, THE "NEEDLE" CRYSTALIZED.¿ IT TOOK 9 MONTHS FOR THE PATIENT TO GET BACK TO A NORMAL LEVEL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A CATHETER BLOCKAGE IN 2008. THE CATHETER HAD TO BE REPLACED BECAUSE IT HAD CLOGGED UP AND WAS NOT DELIVERING CORRECTLY. IT WAS NOT KNOWN WHAT WAS CONTAINED IN THE PUMP AT THE TIME OF THE EVENT, BUT THE PUMP HAD PREVIOUSLY BEEN USED TO DELIVER MORPHINE AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R EXPLANTED:| PROGRAMMER MODEL PROGRAMMER