BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3160099 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10055
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MDT 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 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N252652, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED TO HAVE MAGNETIC RESONANCE IMAGING (MRI) TO ¿RULE OUT IF SHE HAD A STROKE OR ANYTHING.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE EVENT HAD NOTHING TO DO WITH THE DEVICE OR THE MEDICATION THAT IT WAS DELIVERING. THE PATIENT WAS ¿FINE.¿ THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261033 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other