BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3714860 · Received March 31, 2014

    Report

    Report Number
    3007566237-2014-00866
    Event Type
    Injury
    Date Received
    March 31, 2014
    Date of Event
    January 1, 1998
    Report Date
    March 19, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: UNK, LOT: UNK, IMPLANTED: UNK, EXPLANTED: UNK. (B)(4). THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE LITERATURE (MONTH AND DAY UNKNOWN). IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    ROYAL. M. A., WIESEMEYER, D. I., GORDON, V. INTRATHECAL OPIOID CONVERSIONS: THE IMPORTANCE OF LIPOPHILICITY. NEUROMODULATION 1998. 1(4); 195-197. SUMMARY: AN INTRATHECAL OPIOID INFUSION USING AN IMPLANTED PROGRAMMABLE PUMP IS FREQUENTLY USED FOR CONTROLLING REFRACTORY PAIN. MORPHINE, WHICH IS THE ONLY OPIOID PRESENTLY APPROVED BY THE FDA FOR USE IN SUCH PUMPS, OCCASIONALLY FAILS TO WORK OR IS NOT TOLERATED BY THE PATIENT; THEREFORE, OTHER OPIOIDS ARE CONSIDERED FOR INFUSIONS. WHEN SWITCHING FROM ONE DRUG TO ANOTHER, IT IS IMPORTANT TO CONSIDER NOT ONLY EQUIANALGESIC DOSE CONVERSIONS, BUT ALSO LIPOPHILICITY. WE REPORT ON THREE CASES THAT DEMONSTRATE THE NEED TO USE ONLY A FRACTION OF THE EQUIANALGESIC DOSE WHEN SHIFTING FROM LIPOPHILIC TO NON-LIPOPHILIC OPIOIDS IN SUCH INFUSIONS. CASE 1: (B)(6) OLD MALE, WAS ADMITTED TO THE PAIN EVALUATION <(>&<)> TREATMENT CENTER (TULSA, OK) FROM AN OUTLYING HOSPITAL FOR EXCESSIVE SEDATION, RESPIRATORY DEPRESSION, NAUSEA, VOMITING, AND COFFEE GROUND EMESIS SEVERAL DAYS AFTER AN INTRATHECAL INFUSION PUMP CHANGE FROM SUFENTANIL TO MORPHINE BY A LOCAL PAIN PHYSICIAN. THE PATIENT HAD AN INFUSION PUMP (SYNCHROMED PUMP, MEDTRONIC, INC., MINNEAPOLIS) IMPLANTED FIVE YEARS PREVIOUSLY. FROM THE RECORD REVIEW, THE PATIENT APPARENTLY WAS STARTED ON MORPHINE, SLOWLY INCREASING FROM 10 MG TO 45 MG PER 24H AND THEN CHANGED TO SUFENTANIL, SLOWLY INCREASING FROM 20 TO 60MCG PER 24 H OVER SEVERAL MONTHS. TWO DAYS PRIOR TO THE HOSPITALIZATION, THE PATIENT WAS CHANGED BACK TO MORPHINE, 50 MG PER 24 H. THE FOLLOWING DAY, WHEN THE PATIENT COMPLAINED OF EXCESSIVE SEDATION, HIS PHYSICIAN DECREASED HIS DOSE TO 45 MG; BUT THE PATIENT CONTINUED TO SUFFER SEDATION, BECAME DIFFICULT TO AROUSE, AND DEVELOPED RESPIRATORY DEPRESSION AND RESPIRATORY ACIDOSIS. HE WAS REFERRED TO US FOR MANAGEMENT OF THE PUMP INFUSION. THE PATIENT¿S OTHER PAST MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND CHRONIC DEPRESSION. HIS MEDICATIONS WERE FUROSEMIDE, ZESTORETIC, AND PAROXETINE. HE HAD BEEN ON IMMEDIATE RELEASE MORPHINE (= 120 MG PER DAY) IN ADDITION TO THE SUFENTANIL INFUSION PRIOR TO RECEIVING MORPHINE IN HIS PUMP. USING NALOXONE TO HELP DECREASE THE IMMEDIATE RESPIRATORY EFFECTS, WE DECREASED HIS INFUSION TO 25 MG PER 24 H AND THEN OVER THE NEXT WEEK, WE DECREASED IT TO 5 MG PER 24 H. HIS RESPIRATORY DEPRESSION AND SEDATION CLEARED WHILE HIS PAIN REMAINED WELL CONTROLLED. OVER THE NEXT SEVERAL MONTHS THE PATIENT CONTINUED TO EXPERIENCE PAIN RELIEF WITH THE DAILY MORPHINE INFUSION OF 5 MG AND REPORTED NO SIGNIFICANT SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188317 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R