BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2010579 · Received March 1, 2011

    Report

    Report Number
    3007566237-2011-01538
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    October 5, 2010
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESTLESSNESS, SALTY TASTE SENSATION, REDUCED APPETITE, INCREASING SUICIDAL IDEATION (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO REGARDING THE DEVICE MODEL/SERIAL NUMBER HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: CHRISTOPH MAIER, HANS-HELMUT GOCKEL, KAI GRUHN, ELENA K. KRUMOVA, MARC-ANDREAS EDEL. INCREASED RISK OF SUICIDE UNDER INTRATHECAL ZICONOTIDE TREATMENT - A WARNING. PAIN. 2011; 152: 235-237. SUMMARY: THE AUTHORS PRESENT TWO CASES SUPPORTING THE SUSPICION OF ZICONOTIDE INDUCED SUICIDALITY. IN BOTH CASES, THERE WAS NO DEPRESSIVE SYMPTOMS AT THE TIME OF TREATMENT INITIATION. REPORTABLE EVENT: IT WAS REPORTED THAT A PT (CASE 2) WITH SEVERE PAIN HAD INTRATHECAL ZICONOTIDE TREATMENT INITIATED BY ANOTHER CLINIC 6 MONTHS PRIOR TO BEING SEEN BY THE AUTHORS. ON ADMISSION, SHE REPORTED TO ANALGESIC EFFECT FROM HER ZICONOTIDE TREATMENT, HOWEVER, SHE REPORTED INCREASING SYMPTOMS OF COGNITIVE AND PSYCHIATRIC DYSFUNCTION; THESE INCLUDED, GENERAL RESTLESSNESS, SEVERE SLEEP DISTURBANCE, SALTY TASTE SENSATION, NAUSEA, ROTATORY VERTIGO, REDUCED APPETITE AND INCREASING SUICIDAL IDEATION. FURTHERMORE, DISORDERS OF SPEECH, ATTENTION, MEMORY AND ORIENTATION, AND AUDITORY HALLUCINATIONS RELATED TO THE PERCEPTION OF MUSIC AND NOISES EMERGED. DEPRESSION SCORE WAS SEVERE; NO ABNORMALITIES WERE SEEN FOLLOWING NEUROLOGICAL EXAMINATION, NEUROPSYCHOLOGICAL TESTING OR THE CEREBRAL MRI. AN EEG SHOWED NO ABNORMALITIES AND DEMONSTRATED A NORMAL ALPHA-RHYTHM. THE PT HAD A 20-YEAR HISTORY OF DEPRESSION, THE FIRST EPISODE HAD OCCURRED FOLLOWING A STRESSFUL LIFE EVENT. SHE HAD ALSO A HISTORY OF THE SUICIDE ATTEMPT THROUGH TRICYCLIC ANTIDEPRESSANTS OVERDOSE 18 YEARS AGO. SHE HAD ALSO EXPERIENCED POSTPARTUM DEPRESSION TWICE BUT HAD BEEN SUCCESSFULLY TREATED. FOR THE THREE YEARS PRIOR TO THE INITIATION OF ZICONOTIDE TREATMENT, SHE HAD BEEN FREE OF DEPRESSIVE SYMPTOMS WHILST TAKING 30 MG/DL FLUOXETINE. AFTER HER SKIING INCIDENT 14 YEARS BEFORE, SHE WAS INITIALLY TREATED UNSATISFACTORILY WITH ORAL AND TRANSDERMAL OPIOIDS AND A STIMULATING DEVICE, ALL OF WHICH PROVED INEFFECTIVE. SUBSEQUENTLY, AN INTRATHECAL MORPHINE PUMP WAS STARTED WHICH INITIALLY PROVIDED GOOD ANALGESIA, HOWEVER, ITS EFFECTIVENESS WANED DURING THE NEXT 3.5 YEARS. FIVE MONTHS BEFORE ADMISSION TO OUR CLINIC, THE INTRATHECAL TREATMENT WAS SWITCHED TO ZICONOTIDE, WHICH WAS BEING GIVEN AT 6 MCG/DAY ON ADMISSION (INITIAL DOSE 1.2 MCG/24 H, TITRATION WITH INCREMENTAL STEPS OF 2.5 MCG/DAY, CUMULATIVE DOSAGE ABOUT 2900 MCG). DURING THE EXPLORATION AFTER ADMISSION TO OUR CLINIC, THE PT "REPORTED THE RETURN OF DEPRESSIVE SYMPTOMS AND THE BEGINNING OF INCREASING SUICIDAL IDEATION ABOUT TWO MONTHS AFTER THE INITIATION OF THE ZICONOTIDE TREATMENT. SHE ALSO DESCRIBED SEVERAL EPISODES PARTIAL OR TOTAL AMNESIA. DURING THESE EPISODES SHE WAS INVOLVED IN TWO SEVERE ROAD TRAFFIC ACCIDENTS. IT WAS UNCLEAR IF THESE CAR ACCIDENTS WERE, CONSCIOUSLY OR UNCONSCIOUSLY, SUICIDE ATTEMPTS. DESPITE THESE INCREASINGLY WORRYING PSYCHIATRIC SYMPTOMS, THE PT UNDERWENT NO FORMAL PSYCHOLOGICAL OR PSYCHIATRIC EVAL. ON ADMISSION TO THE CLINIC, THE PT'S MODERATE TO SEVERE DEPRESSIVE EPISODE WITH SUICIDAL IDEATION WAS RECOGNISED. THE AUTHORS IMMEDIATELY INITIATED THE WITHDRAWAL OF THE ZICONOTIDE TREATMENT. THIS RESULTED IN A MODERATE RECOVERY FROM THE DEPRESSION (HAMD-17 SCORE: 22) AND REMISSION OF SUICIDAL IDEATION AFTER 14 DAYS. THE PT REPORTED PAIN RELIEF (NRS 5-6) UNDER INTENSIVE PHYSIOTHERAPY IN COMBINATION WITH ORAL DRUG TREATMENT (ETORICOXIB, FLUPIRTINE, DULOXETINE AND PREGABALIN) AND THE INTRATHECAL PUMP WAS REMOVED. IN THE SEVEN MONTHS FOLLOWING DISCHARGE, THE PT'S PAIN WAS WELL CONTROLLED AND THERE HAD BEEN NO RELEASE IN PSYCHIATRIC SYMPTOMS. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2011-01537.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED:| EXPLANTED: