BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED

    MDR report key: 2010442 · Received March 1, 2011

    Report

    Report Number
    3007566237-2011-01537
    Event Type
    Death
    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) - SUICIDE. 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 ADD'L INFO WAS AVAILABLE, ADD'L 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 ONE PT (CASE 1) HAD A HISTORY OF SEVERE PAIN IN BOTH FEET DUE TO A BILATERAL AXONAL POLYNEUROPATHY OF AN UNCLEAR ETIOLOGY. CURRENT PAIN MEDICATION WAS TRANSDERMAL BUPRENORPHINE, MORPHINE AND ORAL PREDNISOLON. THE PATIENT'S MEDICAL HISTORY WAS CHARACTERIZED BY MULTIPLE UNSUCCESSFUL TREATMENTS, INCLUDING SEVERAL TRICYCLIC ANTIDEPRESSANTS, ANTICONVULSANTS AND WEAK ACTING OPIOIDS. TWO YEARS PREVIOUSLY, A POSSIBLE DIAGNOSIS OF DEPRESSION WAS CONSIDERED, HOWEVER THIS DIAGNOSIS WAS NOT SUPPORTED BY A FORMAL PSYCHIATRIC ASSESSMENT. ON ADMISSION TO THE PAIN CLINIC TWO MONTHS PRIOR TO ZICONOTIDE TREATMENT, THE PT HAD ONLY SLIGHTLY INCREASED SUBSCORES FOR ANXIETY AND DEPRESSION, RESPECTIVELY 13 AND 17 POINTS, THIS PSYCHOLOGICAL EVALUATION REVEALED NO EVIDENCE OF DEPRESSIVE DISORDER OTHER THAN SLEEP DISTURBANCE, THE CAUSE OF WHICH WAS DESCRIBED TO NIGHT PAIN. AN INTRATHECAL PAIN TREATMENT WAS INITIATED WITH ZICONOTIDE 0.5 LG/DAY, WITH A STEPWISE INCREASE OF THE DOSE DURING THE FOLLOWING 9 DAYS TO 1.2 MCG/DAY. THE ORAL OPIOID TREATMENT WAS SWITCHED TO SUBLINGUAL BUPRENORPHINE. THE PT REPORTED SOME PAIN RELIEF, BUT THE ZICONOTIDE DOSAGE WAS INCREASED IN INCREMENTAL STEPS FROM 1.2 UP TO 4.4 MCG/DAY WITHIN THREE WEEKS WITHOUT ANY SIDE EFFECTS. AT THIS TIME, THE ANXIETY AND DEPRESSION SUBSCORES HAD DECREASED TO 5 AND 7, RESPECTIVELY. THE PT WAS DISCHARGED 22 DAYS LATER WITH AN AVERAGE PAIN LEVEL OF 3-4 (NRS). THREE DAYS LATER, THE PT WAS SEEN FOR PUMP FILLING AND DISPLAYED NO BEHAVIOR INDICATIVE OF SUICIDAL IDEATION. AT THIS POINT, THE PATIENT'S DEPRESSION SCORE WAS 6. HOWEVER, 16 DAYS LATER, 8 WEEKS SINCE THE INITIATION OF INTRATHECAL ZICONOTIDE (CUMULATIVE DOSAGE: 779 MCG), THE PT WAS FOUND HUNG AT A NEARBY GARAGE. HIS WIDOW REPORTED THAT HER HUSBAND APPEARED QUITE HAPPY DURING THE PREVIOUS TWO WEEKS. HOWEVER, HE HAD FOR THE FIRST TIME EXPRESSED SUICIDAL IDEAS TO HER DURING THIS PERIOD.

    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 66 YR Death EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED: