BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3123844 · Received May 22, 2013

    Report

    Report Number
    6000030-2013-00120
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    May 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L73869, IMPLANTED: (B)(6) 2000. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT THROUGH WITHDRAWAL AND ALMOST DIED; THE PATIENT ALMOST HAD A HEART ATTACK. THE PATIENT WAS SEEN IN THE E.R. AND IN THE PAIN CLINIC. THE CAUSE OF THE WITHDRAWAL WAS UNKNOWN. 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
    225961 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other