BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3904233 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12311
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS BEING BROUGHT TO THE HOSPITAL (ER) BECAUSE THEY COULD ¿SEE¿ THE CATHETER OUTSIDE OF SKIN. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION LATER REPORTED THE PATIENT WAS SEEN IN THE HOSPITAL. THE PUMP POCKET WAS COMPLETELY OPEN AND THE CATHETER WAS VISIBLE. THE NEUROSURGEON WAS DECREASING THE DOSE AND PLANNED ON TAKING OUT THE PUMP. ADDITIONAL INFORMATION LATER REPORTED THE HCP EXPLANTED THE ENTIRE SYSTEM. ADDITIONAL INFORMATION LATER REPORTED THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384604 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R