BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200242 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-01132
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    August 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT# N072728, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLERGIC TO THE ORAL MEDICATION KADIAN. THE PATIENT TOOK KADIAN, AND IN 24 HOUR LATER, THE PATIENT WAS LAYING IN HIS LIVING ROOM FLOOR CURLED UP. THE PATIENT¿S BODY WAS ESSENTIALLY OUT OF CONTROL. THE PATIENT¿S MUSCLES WERE JUST GOING CRAZY AND TERRIBLY SHAKING. THE PATIENT WAS CRYING AND HALLUCINATING SOMETHING TERRIBLE AND NOBODY WOULD HELP HIM. THE PATIENT STATED HE HAD FIVE MASSIVE MELTDOWNS LIKE THAT ¿WHERE THE PSYCHO PART OF IT WAS JUST UNBELIEVABLE.¿ THE PATIENT THOUGHT HE WAS GOING TO DIE. THE PATIENT STATED HIS WIFE WENT THROUGH THIS WHOLE SYSTEM OF CHECKING HIS DRUG INTERACTIONS. AND AFTER SHE PUT IN ALL OF THE OTHER 15 MEDICATIONS THE PATIENT TAKES AND SHE ENTERED KADIAN INTO THIS THING, THE COMPUTER JUST WENT CRAZY.¿ THE PATIENT WAS TAKING THE KADIAN ON HIS WAY HOME FROM A PUMP REFILL. THEN THE PATIENT WENT INTO A PSYCHOTIC MELTDOWN AND DISCUSSED THE INTERACTIONS OF THE DRUG WITH KADIAN. THE PATIENT STOPPED TAKING THE MEDICATION AND IN LESS THAN FIVE OR SIX HOURS WAS VIRTUALLY NORMAL. THE PATIENT STATED WITHIN 24 HOURS OF TAKING THE ORAL MEDICATION, HE HAD HIS FIRST MAJOR MELTDOWN. THE MELTDOWNS HAPPENED ANYWHERE FROM THREE TO FIVE DAYS APART. THE PATIENT REPORTED HE WAS STILL HAVING SOME MASSIVE PROBLEMS. "THE PATIENT STATED WHENEVER HE DO ANY PHYSICAL ACTIVITY THAT INVOLVES HIS LUMBAR, HE HAD A HIS BODY SHUT OFF AND HE DID NOTHING BUT SLEEPING." THE PATIENT COULDN¿T EVEN HARDLY GET OUT OF BED. THE PATIENT THOUGHT SOMETHING WAS REALLY WRONG IN HIS LUMBAR. THE PATIENT STATED THIS STARTED OCCURRING AFTER PRIMARILY TAKING THE KADIAN. THE PATIENT WAS HAVING THE PROBLEM WHEN HE WENT OUT AND SHOVELED SOME GRAVEL OR DID SOME LANDSCAPING. THE MORPHINE WAS DELIVERED IN THE PUMP. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299293 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Other