BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 2992517 · Received March 7, 2013

    Report

    Report Number
    6000030-2013-00050
    Event Type
    Death
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL(B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CAUSE OF DEATH WAS CARDIAC DISEASE, AND IT WAS UNRELATED TO THE PUMP.

    Description of Event or Problem · 1

    A PATIENT DEATH WAS REPORTED APPROXIMATELY TWENTY-FOUR HOURS AFTER A REFILL WAS PERFORMED IN THEIR HOME. AS OF THE DATE OF THIS REPORT, THE PATIENT'S HEALTHCARE PROVIDER WAS WORKING TO DETERMINE IF THE REFILL HAD ANYTHING TO DO WITH THE PATIENT'S DEATH. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97417 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Death