BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3202637 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00364
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    May 24, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS SCHEDULED TO HAVE MAGNETIC RESONANCE IMAGING (MRI) DONE ON (B)(6) 2012 OF HER BRAIN AND THE REST OF THE BODY. THE PATIENT HAD ALWAYS BEEN TOLD THAT SHE COULD NOT HAVE AN MRI BECAUSE THE ¿POWER OF THE MAGNET COULD CRACK THE PUMP ITSELF¿, SO THE PATIENT HAD TO WAIT IN PAIN TO HAVE PROCEDURES. IT WAS NOTED THAT THE MRI WAS ORDERED BECAUSE THERE WAS A SUSPECTED PUMP ISSUE AND THE PATIENT HAD ADDITIONAL HERNIATED DISC IN HER LOWER BACK. THE PUMP WAS USED TO DELIVER MORPHINE, BACLOFEN AND AN UNKNOWN DRUG. ADDITIONAL FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT PATIENT NO LONGER HAD CONCERNS WITH DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302671 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1