BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3172724 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10440
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2013 THAT THE PATIENT WAS TO HAVE AN MRI AS HIS NEUROLOGIST WANTED CHECK BRAIN ACTIVITY BUT HADN¿T SCHEDULED A DATE YET BECAUSE THEY WERE WAITING FOR INSURANCE TO APPROVE IT. THE REASON FOR MRI WAS NOTED TO BE SEIZURES AND THAT PATIENT HAD SEIZURES IN HIS SLEEP. IT WAS STATED THAT THE SEIZURES HAD BEEN GOING ON FOR QUITE A WHILE AND HAD STARTED IN APPROXIMATELY 2010. THE PATIENT¿S DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN. IT WAS LATER REPORTED AS OF THE DATE OF THIS REPORT THAT PATIENT HAD ATTEMPTED AN MRI ON (B)(6) 2013 AND APPROXIMATELY 5 TO 10 SECONDS AFTER STARTING THE MRI PATIENT FELT A VIBRATION SENSATION, DIZZINESS, AND THEY WERE SEEING DOUBLE. THE PUMP ALSO ALARMED. THE PATIENT INSTRUCTED THE HEALTH CARE PROVIDER (HCP) TO STOP THE MRI BECAUSE IT WAS ¿PULLING¿ AND THEY WERE FEELING LIGHTHEADED. IT WAS NOTED THAT THIS WAS THE PATIENT¿S FIRST MRI SINCE HAVING THEIR PUMP IMPLANTED. THE PUMP WAS LATER ASSESSED BY THE HEALTH CARE PROVIDER ON THE SAME DAY FOLLOWING THE MRI, AND THE PUMP WAS DETERMINED TO HAVE RESET ITSELF BACK TO ITS NORMAL SETTINGS. AS OF THE DATE OF THIS REPORT, THE VIBRATION SENSATION, DIZZINESS, AND DOUBLE VISION HAD SUBSIDED SINCE THE PUMP WAS CHECKED. IN REGARDS TO THE SEIZURES IT WAS STATED THAT THE PATIENT HAS HAD SEIZURES IN THE PAST, AND THEY WERE GOING TO SEE HOW MUCH BRAIN DAMAGE THE SEIZURES MAY HAVE CAUSED OVER THE YEARS. FOLLOW-UP INFORMATION RECEIVED FROM THE PHYSICIAN IN REGARDS TO SEIZURE, STATED THAT THERE WAS NO ADVERSE EVENT FROM THE INTRATHECAL BACLOFEN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274424 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR