BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYCHROMED

    MDR report key: 1111564 · Received August 13, 2008

    Report

    Report Number
    2182207-2008-04922
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    May 10, 2008
    Report Date
    July 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER BEING ON PRIALT FOR 8 MONTHS, THE PT STARTED DEVELOPING MENTAL STATUS CHANGE (CONFUSION, FORGETFULNESS) WHICH WAS THOUGHT TO BE RELATED TO PRIALT. THE PRIALT WAS REMOVED FROM THE PUMP AND A SMALL AMOUNT OF BACLOFEN WAS ADDED; THERE WAS RELATIVE IMPROVEMENT FOR TWO DAYS, WHEN THE PT EXPERIENCED THE ODD SENSATION OF NOTING SMELL OR TASTE OF METAL IN HIS MOUTH. HE DIDN'T SLEEP WELL THAT NIGHT. HE SLEPT A FAIR AMOUNT THE NEXT MORNING, BUT BY THE AFTERNOON WAS WRITHING, AGITATED AND COULD NOT SIT STILL AND COMPLAINED OF INCREASED PAIN AND SEEMINGLY HAVING A DIFFICULT TIME SITTING STILL OR CONTROLLING HIS BODILY MOVEMENTS. THE PT PRESENTED WITH MENTAL STATUS CHANGES INCLUDING CONFUSION AND FORGETFULNESS. THE PT WAS ADMITTED TO THE HOSP. THE PT EXPERIENCED AGITATION, DELIRIUM, AND RESTLESSNESS. THE PT REQUIRED FOUR POINT RESTRAINTS AND TWO DOSES OF HALDOL (5MG) AND ONE DOSE OF ATIVAN (2 MG). EFFEXOR XR AND NAMENDA WERE DISCONTINUED AND SUPPORTIVE TREATMENT WAS STARTED. THE PT WAS DIAGNOSED WITH POSSIBLE SEROTONIN SYNDROME. THE PT HAD INCREASED BLOOD PRESSURE AND HEART RATE WHICH RETURNED TO NORMAL WITH CURRENT TREATMENT. THE PT WAS ALSO STARTED ON ANTIBIOTIC TREATMENT DUE TO INCREASED WHITE BLOOD CELL COUNT AND INABILITY TO RULE OUT INFECTION. THE PT ALSO HAD ELEVATED CARDIAC ENZYMES. THE CAT SCAN OF THE HEAD WAS WITHIN NORMAL LIMITS. THE PT EXPERIENCED SOME FLUSHING, MILD ELEVATION OF CK, LOW FEVER, AND ELECTROLYTE ABNORMALITY. MEDICATIONS GIVEN IN THE HOSP INCLUDED: LOPRESSOR (5 MG, IV, EVERY 4 HRS), LEVAQUIN (500 MG, IV, DAILY), MORPHINE SULFATE (5 MG, AS NECESSARY, IV), ATIVAN 1-3 MG, AS NECESSARY, IV OR IM), AND HALDOL (5 MG, IV, EVERY ONE HR, AS NECESSARY). BY THE MID-MORNING OF TWO DAYS AFTER HE WAS ADMITTED TO THE HOSP, THE PT "AWAKENED" AND THERE WAS SPONTANEOUS RESOLUTION OF NEUROPSYCHIATRIC SYMPTOMS. THE PT REMAINED STABLE THE NEXT DAY AND CONDITION AT DISCHARGE, THAT SAME DAY, WAS GOOD -ESSENTIALLY 'RETURNED TO NORMAL". THE PT'S DOSE OF MEDICATION DELIVERED VIA THE PUMP WAS THE SAME SEVERAL WEEKS AFTER THE PT RECOVERED AS IT HAD BEEN WHEN HE WAS ADMITTED TO THE HOSP. THE PT RECOVERED WITHOUT SEQUELA. THE DRUGS CONTAINED IN THE PUMP THROUGHOUT THE EVENT AND AFTERWARD WAS A MIXTURE OF BACLOFEN AND BUPIVACAINE. AT THE TIME OF THE EVENT THE PT'S CONCOMITANT ORAL MEDICATIONS WERE ACTIQ POPS, EFFEXOR XR, AND NAMENDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYCHROMED LKK MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R EXPLANTED| PROGRAMMER MODEL PROGRAMMER| CATHETER MODEL CATHETER