BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3097192 · Received May 7, 2013

    Report

    Report Number
    3007566237-2013-01545
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    May 25, 2012
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL: UNK, SERIAL/LOT#: UNK. . THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4). DECLINE IN FUNCTION. DIURESIS. YAWNING.

    Description of Event or Problem · 1

    JACKSON, T. P., LONERGAN, D. F., TODD, R. D., MARTIN, P. R. INTENTIONAL INTRATHECAL OPIOID DETOXIFICATION IN 3 PATIENTS: CHARACTERIZATION OF THE INTRATHECAL OPIOID WITHDRAWAL SYNDROME. PAIN PRACTICE : THE OFFICIAL JOURNAL OF WORLD INSTITUTE OF PAIN. 2013;13(4):297-309. DOI: 10.1111/J.1533-2500.2012.00584.X. SUMMARY: THREE PATIENTS WITH INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS), INADEQUATE PAIN CONTROL, AND DECLINING FUNCTIONALITY UNDERWENT ABRUPT IT OPIOID CESSATION. THIS WAS ACCOMPLISHED THROUGH A STANDARDIZED PROTOCOL WITH SYMPTOM-TRIGGERED ADMINISTRATION OF CLONIDINE AND BUPRENORPHINE, MONITORED USING THE CLINICAL OPIATE WITHDRAWAL SCALE. REPORTED EVENT: AN (B)(6) WOMAN WITH A LONG HISTORY OF LUMBAR PAIN, HYPERTENSION, AND OSTEOARTHRITIS PRESENTED FOR EVALUATION. SHE HAD UNDERGONE 3 LUMBAR SURGERIES AND EVENTUALLY HAD AN IDDS PLACED AT AN OUTSIDE CENTER 9 YEARS PRIOR. SHE REPORTED THAT OVER THE PAST YEAR, THE IDDS WAS NOT PROVIDING CONSISTENT OR ADEQUATE ANALGESIA DESPITE UPWARD TITRATION FROM 0.37 TO 0.76 MG OF HYDROMORPHONE/DAY. SHE WAS ALSO RECEIVING 3 MG/DAY OF IT BUPIVACAINE AND INTERMITTENT ORAL HYDROMORPHONE (4 MG EVERY 4 HOURS AS NEEDED). THE INCREASE IN IT AND ORAL HYDROMORPHONE DOSAGE CORRESPONDED WITH A DECLINE IN FUNCTION AND DIFFICULTY PERFORMING ACTIVITIES OF DAILY LIVING. SHE COMPLAINED OF AN AVERAGE OF 5/10 PAIN IN HER LOW BACK AND LATERAL THIGHS. ON PHYSICAL EXAM, LOWER EXTREMITY EDEMA WAS NOT NOTED (IN CONTRAST WITH CASES 1 AND 2). THE DECISION WAS MADE TO PROCEED WITH INPATIENT DETOXIFICATION IN A MONITORED HOSPITAL WARD, RATHER THAN THE ICU, GIVEN THE MILD WITHDRAWAL SYMPTOMS OBSERVED WITH THE FIRST 2 CASES. ADMISSION VITAL SIGNS WERE AS FOLLOWS: BLOOD PRESSURE 195/78 (WHICH IMPROVED FOLLOWING CLONIDINE ADMINISTRATION), PULSE 64, RESPIRATORY RATE 18, OXYGEN SATURATION 96%, AND WEIGHT 72.6 KG. HER LAST DOSE OF ORAL HYDROMORPHONE WAS 10 HOURS PRIOR TO ADMISSION. WITHIN 24 HOURS OF CESSATION OF THE IDDS, SHE STARTED EXPERIENCING SYMPTOMS OF WITHDRAWAL, WHICH INCLUDED SEVERE PAIN IN HER BACK AND LEGS, HYPERTENSION (EFFECTIVELY TREATED WITH CLONIDINE), DIURESIS, YAWNING, FREQUENT SNEEZING, RESTLESSNESS, LACRIMATION, AND AGITATION. SHE WAS TREATED WITH ORAL CLONIDINE ACCORDING TO THE COWS PROTOCOL, WITH THE MAXIMUM SCORE OF 8 AND MAXIMUM TOTAL DOSE OF 0.8 MG OF CLONIDINE/24-HOUR PERIOD (FIGURE 3). SHE WAS ALSO TREATED WITH GABAPENTIN AND ACETAMINOPHEN. SHE DID NOT RECEIVE ANY OPIOIDS, AND THE WITHDRAWAL SYMPTOMS WERE NOT SEVERE ENOUGH TO QUALIFY FOR BUPRENORPHINE ADMINISTRATION. SYMPTOMS OF WITHDRAWAL HAD SUBSIDED BY THE FOURTH HOSPITAL DAY. SHE WAS DISCHARGED ON THE 5TH DAY WITH A PAIN SCORE OF 4/10 AND REPORTED MUCH LESS PAIN IN HER LEGS WHILE WALKING, WHICH SHE ASSOCIATED WITH THE CLONIDINE DOSES. IN CONTRAST WITH THE FIRST 2 CASES, SHE DID NOT EXPERIENCE SIGNIFICANT WEIGHT LOSS THROUGHOUT HER HOSPITAL STAY. THE IDDS WAS FILLED WITH SALINE AND PROGRAMMED AT A MINIMAL RATE. AT ROUTINE 3-MONTH FOLLOW-UP, THE PATIENT REPORTED THAT SHE WAS DOING EXTREMELY WELL WITH A BASELINE PAIN SCORE OF 2/10. SHE WAS ABLE TO PERFORM ALL ACTIVITIES OF DAILY LIVING AND WAS WALKING 1 MILE DAILY. SHE ALSO REPORTED BETTER CONTROL OF HER HYPERTENSION SINCE DETOXIFICATION. SHE WAS MAINTAINED WITH CLONIDINE 0.1 MG TWICE DAILY, GABAPENTIN 600 MG 3 TIMES DAILY, AND ACETAMINOPHEN AS NEEDED. AT 1 YEAR, THE PATIENT REPORTED THAT HER ACTIVITIES ARE NO LONGER LIMITED BY PAIN. 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
    199435 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R