BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3130677 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08205
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PUMP IMPLANTED IN HER RIGHT FRONT ABDOMEN AND A STIMULATOR IMPLANTED IN HER LEFT LOWER BACK. THE PATIENT HAD RECENTLY BEEN HOSPITALIZED FOR SEVERE LOWER BACK PAIN AND NEEDED TO DO AN MRI. IT WAS REPORTED THAT AN MRI COULD NOT BE PERFORMED WITH A STIMULATOR .THE PATIENT NEEDED THE MRI SO THEY COULD SEE EXACTLY WHAT WAS GOING ON WITH HER BACK. THE PATIENT WAS PLANNING TO CONTACT THE HEALTHCARE PROVIDER (HCP) TO HAVE THE STIMULATOR REMOVED FOR THE MRI TO BE PERFORMED. THE PUMP WAS DELIVERING CLONIDINE, BUPIVACAINE, AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231810 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization