BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2994261 · Received March 8, 2013

    Report

    Report Number
    3007566237-2013-00722
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    September 1, 2009
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. THE EVENT DATE IS APPROXIMATE; THE DAY OF THE MONTH WAS NOT PROVIDED. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    VRBA, I. ZICONOTIDE- NEW POSSIBILITY IN THE INTRATHECALLY ANALGETIC TREATMENT, OUR EXPERIENCE. BOLEST. SUMMARY/REPORTED EVENT: THE FIRST TESTED PATIENT WAS IN (B)(6) 2009, A (B)(6) WOMAN WITH FAILED BACK SURGERY SYNDROME (FBSS) WITH MIXED PAIN WHO HAD BEEN LONG TREATED WITH MORPHINE (6.5 YEARS) ADMINISTERED INTO THE INTRATHECAL SPACE USING A PUMPING SYSTEM (SYNCHROMED EL MADE BY MEDTRONIC) WITH CERTAIN UNDESIRABLE EFFECTS, IN PARTICULAR BREATHING PROBLEMS THAT WERE HARD TO EXPLAIN BY OTHER CAUSES WHEREFORE WE ATTRIBUTED THEM TO THE INTRATHECAL APPLICATION OF MORPHINE. BECAUSE OF THESE ADVERSE EFFECTS AND SOME SIGNS OF EMERGING TOLERANCE, WE DECIDED TO TRY FOR THIS PATIENT EXCHANGING MORPHINE FOR ZICONOTIDE. WE FOLLOWED THE INSTRUCTIONS AND EXPERIENCE THAT AT THAT TIME WE DREW FROM AVAILABLE BOOKS AND ARTICLES. WE GRADUALLY REDUCED THE DOSE OF MORPHINE FROM THE VALUE OF 7.8 MG/DAY TO 2.2 MG/DAY, GRADUALLY ESCALATING THE DOSES OF PER OS MORPHINE MST. GRADUALLY, WE MANAGED TO TRANSFER THE PATIENT FROM THE INTRATHECAL APPLICATION OF MORPHINE WITHOUT SIGNIFICANT WITHDRAWAL SYMPTOMS. AFTER STABILIZING BOTH THE CONDITION AND THE ANALGESIA, WE ENSURED THE CORRECT ZICONOTIDE CONCENTRATION BY REPEATEDLY FLUSHING THE APPARATUS WITH 2 × 25 MCG ZICONOTIDE (2 ML) FOR THE SUBSEQUENT APPLICATION INTO THE INTRATHECAL SPACE. AFTER FILLING THE PUMP WITH 50 MCG OF ZICONOTIDE IN 4 ML OF STERILE SALINE SOLUTION, WE STARTED THE TEST USING THE AT THAT TIME RECOMMENDED INITIAL DOSE 2.4 MCG OF ZICONOTIDE A DAY. OWING TO ZERO EFFECT, WE INCREASED THE DOSE IN THE COURSE OF 16 HOURS BY 50% TO 3.6 MCG/DAY. AFTERWARDS (WITHIN 4-6 HOURS AFTER THE DOSE INCREASE) SIGNIFICANT SIDE EFFECTS APPEARED PARTICULARLY FROM THE AREA OF THE CENTRAL NERVOUS SYSTEM: CONFUSION, HALLUCINATIONS, SLURRED SPEECH, IMPAIRED CONSCIOUSNESS; VENTILATORY PROBLEMS ALSO AROSE (TACHYPNEA). THE ZICONOTIDE APPLICATION WAS IMMEDIATELY STOPPED AND OWING TO THE SIGNIFICANT SIDE EFFECTS, WE NO LONGER CONTINUED THE TEST. THE PATIENT HAD TO BE HOSPITALIZED AT THE SEMI-INTENSIVE UNIT (SIU) OF THE NEUROSURGICAL DEPARTMENT WITH THE NECESSITY OF PARTIAL VENTILATORY SUPPORT. THE CONDITION WAS WITHOUT DEMONSTRABLE ANALGESIC EFFECT, THEREFORE, WE RE-DEPLOYED THE INTRATHECAL MORPHINE WITH AN INITIAL DOSE OF 4.0 MG/DAY AND WITH A GOOD ANALGESIC RELIEF. WITHIN 48 HOURS, THE PATIENT'S CONDITION STABILIZED, SHE REGAINED CONSCIOUSNESS AND HER COGNITIVE FUNCTIONS WERE RESTORED. HOWEVER, IMPAIRED BREATHING PERSISTED WITH THE PRODUCTION OF MUCOPURULENT SPUTUM, THERE WERE HIGH TEMPERATURES WITH SUSPECTED TRACHEOBRONCHITIS AND THE NEED AROSE OF DEPLOYING ANTIBIOTICS. BY OTHER EXAMINATIONS (CT ANGIOGRAPHY) OF THE LUNGS, THE SUSPICION OF SUCCESSIVE EMBOLIZATION OF BOTH LUNGS IN THIS PATIENT WAS CONFIRMED AND ANTITHROMBOTIC TREATMENT WAS DEPLOYED. AFTER 10 DAYS OF TREATMENT, THE PATIENT WAS TRANSFERRED INTO THE CATCHMENT AREA'S INTERNAL DEPARTMENT FOR FINISHING THE TREATMENT OF PULMONARY COMPLICATIONS. THIS PATIENT WAS CERTAINLY NOT THE SUITABLE TYPE OF PATIENT FOR AN INTRATHECAL APPLICATION OF ZICONOTIDE (MENTALLY QUITE UNSTABLE WITH SIGNIFICANT DEPRESSIVE OVERTONES, OFTEN TEARFUL). ON TOP OF THIS, THE INITIALLY DEPLOYED DOSE (2.4 MCG) PROVED TO BE TOO HIGH (EVEN IF RECOMMENDED AT THAT TIME) AND ITS FURTHER INCREASE WAS PREMATURE (16 HOURS OF THE INITIAL APPLICATION), I.E. EARLIER THAN RECOMMENDED NOW. THE PATIENT IS ALSO CURRENTLY VERY PROBLEMATIC, WITH POOR RESPONSE EVEN TO INTRATHECAL MORPHINE, WITH AN INADEQUATE ANALGESIC EFFECT, WITH SYMPTOMS OF TOLERANCE, PERHAPS EVEN HYPERALGESIA, STILL TEARFUL AND DEPRESSED DESPITE TREATMENT BY A PSYCHIATRIST. SHE SEEKS THE RE-TRIAL OF ZICONOTIDE WHILE ABSOLUTELY DENYING THE SIDE EFFECTS THAT SHE DEVELOPED AFTER THE PREVIOUS APPLICATION OF ZICONOTIDE. CERTAINLY FURTHER EXAMINATIONS BY A PSYCHOLOGIST AND A PSYCHIATRIST ARE NECESSARY, "MORPHINE HOLIDAYS" CAN BE CONSIDERED, OR NEW INTRATHECAL DRUG COMBINATIONS CAN BE TESTED (IN THE PAST, THE PATIENT ALREADY HAD THE COMBINATION OF MORPHINE AND CLONIDINE WITHOUT A MAJOR ANALGESIC EFFECT). WE RULED OUT A REPEATED TEST WITH ZICONOTIDE IN THIS PATIENT FOR SEVERAL REASONS, MAINLY BECAUSE OF THE RISK OF THE PATIENT'S SUICIDAL BEHAVIOR AFTER A RE-DEPLOYMENT OF INTRATHECAL ZICONOTIDE. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99400 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8626

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| L| R