BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 7287420 · Received February 21, 2018

    Report

    Report Number
    3007566237-2018-00519
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    October 16, 2017
    Report Date
    February 21, 2018
    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

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PENICHE, A., POREE, L., SCHUMACHER, M., YU, X. INTEGRATING PATIENT-CONTROLLED ANALGESIA USING IMPLANTED INTRATHECAL PUMPS FOR POSTOPERATIVE PAIN MANAGEMENT: A CASE REPORT. ANESTHESIA AND ANALGESIA CASE REPORTS. 2017. DOI: 10.1213/XAA.0000000000000685 SUMMARY: INTRATHECAL PATIENT-CONTROLLED ANALGESIA (IT-PCA) THROUGH IMPLANTED INTRATHECAL INFUSION PUMPS HAS BEEN INCREASINGLY UTILIZED FOR SEVERE CANCER AND CHRONIC NONCANCER PAIN MANAGEMENT. HOWEVER, ITS APPLICATION FOR ACUTE POSTOPERATIVE PAIN MANAGEMENT HAS NOT BEEN REPORTED TO DATE. WE PRESENT A CASE OF A PATIENT WITH AN IMPLANTED INTRATHECAL PUMP FOR CHRONIC NONMALIGNANT BACK PAIN WHO UNDERWENT AN EXTENSIVE SPINAL FUSION SURGERY. THE IT-PCA FUNCTIONALITY OF HER INTRATHECAL PUMP WAS SUCCESSFULLY INTEGRATED INTO HER POSTOPERATIVE MULTIMODAL PAIN REGIMEN. HENCE, IT-PCA CAN BE SAFELY INCORPORATED INTO ACUTE POSTOPERATIVE PAIN MANAGEMENT WITH VIGILANT MONITORING AND CLOSE MULTIDISCIPLINARY COLLABORATION. REPORTED EVENTS: THE PATIENT WAS A (B)(6) WOMAN WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND CHRONIC BACK PAIN DUE TO FAILED BACK SURGERY SYNDROME MANAGED WITH AN IMPLANTED SPINAL CORD STIMULATOR AND AN INTRATHECAL (IT) INFUSION SYSTEM. HER SURGICAL HISTORY IS NOTABLE FOR 17 SPINE SURGERIES FOR SCOLIOSIS INCLUDING THORACIC AND LUMBAR FUSIONS DATING BACK TO THE 1950S. THE PATIENT WAS SCHEDULED TO UNDERGO A T10-TO-PELVIS POSTERIOR SPINAL FUSION SURGERY. THE INPATIENT CHRONIC PAIN SERVICE WAS NOTIFIED ABOUT HER UPCOMING COMPLEX SURGERY IN THE PRESENCE OF AN IT PUMP AND WAS DESIGNATED TO MANAGE THE IT PUMP THROUGHOUT THE PERIOPERATIVE PERIOD. A COMMUNICATION LOOP WAS ESTABLISHED AMONG THE NEUROSURGICAL TEAM, INTRAOPERATIVE ANESTHESIA TEAM, AND CHRONIC INPATIENT PAIN SERVICE TO ENSURE PATIENT SAFETY THROUGHOUT THE PERIOPERATIVE PERIOD. ON THE DAY OF SURGERY, THE PATIENT¿S IT PUMP WAS INTERROGATED. IT INFUSATE COMPONENTS, INFUSATE CONCENTRATIONS, INFUSATE SETTINGS, AND PATIENT-ADMINISTERED DOSE SETTINGS WERE DOCUMENTED. THE IT INFUSATE CONSISTED OF 2.6 MG/ML HYDROMORPHONE, 10 MG/ML BUPIVACAINE, 104 G/ML CLONIDINE, AND 195 G/ML RACEMIC AND PRESERVATIVE-FREE KETAMINE (MEDISCA, QUEBEC). IN ADDITION TO CONTINUOUS DAILY INFUSION OF 1 MG HYDROMORPHONE, 3.8 MG BUPIVACAINE, 40 G CLONIDINE, AND 75 G KETAMINE, SUPPLEMENTAL DOSES OF 0.6 MG HYDROMORPHONE, 2.3 MG BUPIVACAINE, 24 G CLONIDINE, AND 44 G KETAMINE WERE DELIVERED DAILY BY IT-PCA THROUGH 6 PATIENT-ADMINISTERED BOLUSES. THE IT-PCA DOSE ACCOUNTED FOR ABOUT 40% OF HER TOTAL DAILY IT DOSE. THE SAFETY OF IT KETAMINE HAS BEEN DEBATED FOR MORE THAN A DECADE.TO DATE, IT IS NOT RECOMMENDED FOR TREATING CHRONIC NONCANCER PAIN. ALTHOUGH THE PATIENT¿S IT KETAMINE DAILY DOSE WAS AT LEAST 25-FOLD LESS THAN THAT ASSOCIATED WITH NEUROTOXICITY AS REPORTED IN THE LITERATURE (=5 MG/D), THEY EXPRESSED OUR CONCERN ON POTENTIAL NEUROTOXICITY OF LONG-TERM IT KETAMINE USE TO BOTH THE PATIENT AND HER PROVIDERS. THE PATIENT STATED THAT SHE HAD BEEN ON THE IT KETAMINE FOR MORE THAN A YEAR WITHOUT ANY NOTED NEUROLOGICAL DEFICITS. BECAUSE CONTINUING IT KETAMINE WOULD NOT POSE IMMEDIATE INTRAOPERATIVE AND POSTOPERATIVE SURGICAL RISK, THE PATIENT AND HER SURGICAL TEAM DECIDED TO PROCEED WITH FULL UNDERSTANDING OF THE LONG-TERM RISK OF IT KETAMINE USE. THE PATIENT AGREED TO DISCUSS THE USE OF IT KETAMINE WITH HER PAIN PHYSICIAN AFTER DISCHARGE. PREOPERATIVE RADIOGRAPH IN THE OPERATING ROOM CONFIRMED IT CATHETER TIP LOCATION AT THE T4 LEVEL. GIVEN THE POTENTIAL FOR CLONIDINE WITHDRAWAL IN THE EVENT OF INTRAOPERATIVE IT CATHETER DAMAGE, THE APPROPRIATE REPLACEMENT KIT WAS READILY AVAILABLE AT THE TIME OF SURGERY TO ENSURE CONTINUITY OF IT MEDICATION DELIVERY. AT THE END OF SURGERY, THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT FOR CLOSE POSTOPERATIVE MONITORING WITH CONTINUOUS TELEMETRY AND PULSE OXIMETRY. THERE WAS NO INTRAOPERATIVE CATHETER DAMAGE, ALTHOUGH THERE WAS CONCERN FOR LEAKAGE OF INFUSED IT MEDICATIONS IN THE SETTING OF MULTIPLE DURAL TEARS. NONETHELESS, SHE REMAINED HEMODYNAMICALLY STABLE AND DID NOT DEVELOP ANY SIGNS OF CLONIDINE WITHDRAWAL THROUGHOUT HER POSTOPERATIVE COURSE. MECH ANICAL VENTILATION AND IT INFUSION CONTINUED WITH THE ADDITION OF SYSTEMIC INFUSIONS OF PROPOFOL (80 G/KG/MIN), FENTANYL (200 G/H), AND KETAMINE (5 G/KG/MIN). THE ENDOTRACHEAL TUBE WAS REMOVED ON POSTOPERATIVE DAY 1 (POD 1) WITH POOR PAIN CONTROL DESPITE A CONT INUATION OF IV KETAMINE AND FENTANYL INFUSIONS AT THE RATE OF 3 G/KG/MIN AND 200 G/H, RESPECTIVELY. THE PATIENT WAS THEN TRANSITIONED TO IV HYDROMORPHONE PCA WITH 58.8 MG OF HYDROMORPHINE REQUIRED OVER 48 HOURS, AND SHE SUBSEQUENTLY DEVELOPED AN ILEUS ON POD 2. AFTER A MULTIDISCIPLINARY MEETING WITH THE NEUROSURGERY, CRITICAL CARE, INPATIENT PHARMACY, AND NURSING TEAMS, THE PATIENT WAS ALLOWED TO ACTIVATE HER IT-PCA IN THE INTENSIVE CARE UNIT. TO ENSURE PATIENT SAFETY AND APPROPRIATE MONITORING OF IT MEDICATION USAGE, IT WAS ESTABLISHED THAT THE NURSING STAFF WOULD WITNESS AND DOCUMENT EACH IT-PCA ADMINISTRATION AT THE BEDSIDE AND THE CHRONIC PAIN SERVICE WOULD INTERROGATE THE IT PUMP EVERY 48 HOURS TO CONFIRM THE IT-PCA DAILY DOSE THROUGHOUT THE PERIOPERATIVE PERIOD. SHE WAS TRANSFERRED TO A TRANSITIONAL CARE UNIT ON POD 3 AFTER HER PAIN IMPROVED WITH BOTH IT-PCA AND IV HYDROMORPHONE PCA, AS WELL AS SCHEDULED ACETAMINOPHEN AND GABAPENTIN. AFTER THE REINSTITUTION OF THE IT-PCA, THE DAILY IV HYDROMORPHONE DOSE WAS REDUCED TO AROUND 10 MG, AND THE ILEUS RESOLVED ON POD 7. AT THIS TIME, THE PATIENT BEGAN TRANSITIONING TO ORAL OXYCODONE AND HER IV HYDROMORPHONE PCA WAS DISCONTINUED ON POD 9. SHE WAS SUBSEQUENTLY UNEVENTFULLY DISCHARGED TO AN ACUTE REHABILITATION FACILITY ON POD 12 WITH A MULTIMODAL REGIMEN THAT CONSISTED OF OXYCODONE, ACETAMINOPHEN, GABAPENTIN, TIZANIDINE, AND HER IT PUMP WITH UNCHANGED CONTINUOUS INFUSION AND IT-PCA SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128937 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization