BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6670620 · Received June 27, 2017

    Report

    Report Number
    3007566237-2017-02556
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    June 7, 2016
    Report Date
    June 27, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, LOT# SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, LOT# SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WELPE P. [SPINAL CATHETER-ASSOCIATED CEREBROSPINAL FLUID LEAK]. SCHMERZ (BERLIN, GERMANY). 2016. DOI: 10.1007/S00482-016-0117-6 SUMMARY: IN OUR OUTPATIENT PAIN CLINIC AT THE (B)(6) HOSPITAL OF (B)(6), WE ARE TREATING A (B)(6) PATIENT WHO, DESPITE UNDERGOING SEVERAL PROCEDURES ON THE LUMBAR SPINE, SUFFERS FROM PERSISTENT BACK AND LEG PAIN AS PART OF FAILED BACK SURGERY SYNDROME. SEVEN YEARS AGO, SHE WAS THEREFORE GIVEN AN INTRATHECAL PAIN PUMP AT AN EXTERNAL HOSPITAL. REPORTED EVENTS: UNFORTUNATELY, EVEN AFTER CHANGING THE PUMP, INACCURATE RESIDUAL VOLUMES CONTINUED TO OCCUR, ALONGSIDE INADEQUATE ANALGESIA AND INTERMITTENT WITHDRAWAL SYMPTOMS. THEREFORE, AS INTERMITTENT CATHETER OCCLUSIONS WERE SUSPECTED, IT WAS AGREED WITH THE PATIENT THAT THE SPINAL CATHETER WOULD ALSO BE REPLACED. THE CATHETER HAD NOT BEEN INITIALLY REPLACED AT THE SAME TIME AS THE PUMP (AT THE REQUEST OF THE PATIENT), AS SOME YEARS AGO, THE PATIENT HAD SUFFERED FROM CEREBROSPINAL FLUID LEAK SYNDROME AFTER A MYELOGRAM, WHICH WAS TREATED WITH TWO BLOOD PATCHES. THE EXISTING SPINAL CATHETER WAS SURGICALLY REMOVED WITHOUT DIFFICULTY. THE NEW SPINAL CATHETER WASPLACED ONE LEVEL LOWER, BETWEEN LUMBAR VERTEBRAE 2 AND 3, ADJACENT TO THE MIDLINE. THE PLACEMENT WAS PERFORMED WITHOUT DIFFICULTY AND WITH JUST ONE PUNCTURE OF THE DURA. POSTOPERATIVELY, JUST A FEW HOURS AFTER THE PROCEDURE, CEREBROSPINAL FLUID LEAK SYNDROME OCCURRED, WITH THE TYPICAL POSITION-DEPENDENT HEADACHE. AS THIS DID NOT REGRESS AND THE PATIENT WAS INCREASINGLY RESTRICTED IN HER MOBILITY, WE DECIDED TO PERFORM AN EPIDURAL BLOOD PATCH. WE DECIDED ON THIS, AMONG OTHER REASONS, DUE TO THE PATIENT'S HISTORY OF CEREBROSPINAL FLUID LEAK SYNDROME AFTER A MYELOGRAM A FEW YEARS AGO, FOR WHICH THE TREATMENT WITH A BLOOD PATCH WAS SUCCESSFUL. AFTER THE EPIDURAL BLOOD PATCH WITH 30 ML OF AUTOLOGOUS BLOOD, THE PATIENT WAS ALMOST SYMPTOM-FREE AFTER A SHORT PERIOD OF TIME AND WAS DISCHARGED HOME. DURING THE CHECK-UP OF THE WOUND AND REMOVAL OF THE SUTURES 12 DAYS AFTER THE PROCEDURE, THERE WAS SPONTANEOUS DISCHARGE OF CLEAR FLUID FROM THE PARAVERTEBRAL INCISION SITE. THIS WAS INTERPRETED AS SEROUS FLUID. AFTER THIS, THERE WAS RENEWED EXACERBATION OF THE HEADACHE WITHIN JUST A FEW MINUTES. THEREFORE, THE PATIENT UNDERWENT A FURTHER BLOOD PATCH WITH 40 ML OF AUTOLOGOUS BLOOD UNDER OUTPATIENT CONDITIONS, THIS TIME WITH RADIOLOGICAL CONTROL USING A C-ARM. UNFORTUNATELY, THE IMPROVEMENT WAS ONLY SHORT-TERM, DESPITE PERFORMING THIS BLOOD PATCH. AFTER A FEW DAYS, THE PATIENT WAS RE-ADMITTED AS AN IN-PATIENT. CLINICALLY, THE PATIENT PRESENTED WITH THE TYPICAL SYMPTOMS OF CEREBROSPINAL FLUID LEAK SYNDROME AND POSTDURAL PUNCTURE HEADACHE. THE PATIENT ALSO HAD SYMPTOMS WHEN LYI NG DOWN. THERE WAS PERSISTENT DISCHARGE OF CLEAR FLUID IN THE SURGICAL AREA OF THE PARAVERTEBRAL INCISION SITE. THE INFLAMMATORY MARKERS WERE NORMAL AND THERE WAS NO CLINICAL EVIDENCE OF MENINGITIS OR OTHER INFECTIONS. THE NEUROLOGICAL EXAMINATION WAS ALSO NORMAL. TO ESTABLISH OR RULE OUT A DURAL LEAK, A MAGNETIC RESONANCE IMAGING (MRI) SCAN OF THE LUMBAR SPINE WAS CARRIED OUT. THIS SHOWED A SMALL COLLECTION OF CEREBROSPINAL FLUID AT LEVEL L1/2 - WHICH CORRESPONDED TO THE FORMER PUNCTURE SITE OF THE PREVIOUS CATHETER. THE NEW CATHETER COULD NOT BE FULLY VISUALIZED. THERE WAS NO CLEAR EVIDENCE OF A CEREBROSPINAL FLUID LEAK OR COLLECTION OF CEREBROSPINAL FLUID AT LEVEL L2/3. DESPITE CONSERVATIVE THERAPY MEASURES, THE HEADACHES DID NOT REGRESS. BEFORE PERFORMING A FURTHER BLOOD PATCH, WE DECIDED TO CHECK THE PUMP, VISUALIZE THE SPINAL CATHETER, AND TAKE A SAMPLE OF CEREBROSPINAL FLUID. THE CEREBROSPINAL FLUID WAS MILDLY CLOUDY AND WAS SENT FOR MICROBIOLOGICAL TESTING. THE C-ARM IMAGE WITH CONTRAST AGENT SHOWED A LEAK IN THE SPINAL CATHETER, WHICH EXPLAINED THE SYMPTOMS. THE PATIENT HAD CEREBROSPINAL FLUID LEAK SYNDROME DUE TO A SPINAL CATHETER LEAK WITH DISCHARGE OF CEREBROSPINAL FLUID OUT OF THE PARAVERTEBRAL INCISION SCAR AND SUBSEQUENTLY DEVELOPING CATHETER-ASSOCIATED MENINGITIS WITH COAGULASE-NEGATIVE STAPHYLOCOCCI. PRIMARILY, THEY PLANNED A REVISION PROCEDURE TO ELIMINATE THE LEAK AND RE-CONNECT THE SPINAL CATHETER. HOWEVER, AS THE TESTS SHOWED THERE WERE ALREADY 2171 LEUKOCYTES PER MICROLITER IN THE CEREBROSPINAL FLUID (NORMAL LEVEL <(><<)> 4 CELLS PER MICROLITER) AND THE SYSTEMIC INFECTION PARAMETERS HAD ALSO INCREASED (LEUKOCYTES 11 × 109/L, C-REACTIVE PROTEIN 67 MG/L), THEY ASSUMED AN INFECTION WITH MENINGEAL INVOLVEMENT AND DECIDED TO REMOVE ALL FOREIGN MATERIAL. THE BACTERIOLOGICAL TESTS SHOWED EVIDENCE OF COAGULASE-NEGATIVE STAPHYLOCOCCI. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT WITH FLUCLOXACILLIN FOR 10 DAYS IN ACCORDANCE WITH THE ANTIBIOGRAM. ALREADY ON THE FIRST DAY AFTER THE PROCEDURE, THE TYPICAL POSTDURAL PUNCTURE AND POSITION-DEPENDENT HEADACHE HAD COMPLETELY REGRESSED. THE PATIENT STILL HAD HEADACHE CAUSED BY THE MENINGEAL IRRITATION. THE INFECTION PARAMETERS ALSO QUICKLY REGRESSED UNDER ANTIBIOTIC THERAPY. OPIOID THERAPY WAS INITIALLY GIVEN AS INTRAVENOUS HYDROMORPHONE WITH AN OPTIONAL ADDITIONAL PATIENT-CONTROLLED BOLUS AND THEN GRADUALLY CHANGED TO ORAL HYDROMORPHONE. THE PATIENT SHOWED HARDLY ANY WITHDRAWAL SYMPTOMS AND HER SYMPTOMS WERE RELATIVELY WELL CONTROLLED WITH THE ORAL ANALGESIA. WE WERE ABLE TO DISCHARGE THE PATIENT HOME ON THE 12TH DAY AFTER THE PROCEDURE IN WHICH THE COMPLETE INTRATHECAL SYSTEM WAS REMOVED. WE DECIDED TO RE-IMPLANT A DRUG PUMP AFTER AN INFECTION-FREE PERIOD OF 3 MONTHS, AS THE ANALGESIC QUALITY OF THE ORAL OPIOID THERAPY WITH HYDROMORPHONE WAS SIGNIFICANTLY LESS EFFECTIVE THAN WITH THE IMPLANTED PAIN PUMP, ABOVE ALL WITH THE PATIENT'S DAILY PHYSICAL EXERTION, AND AS THE PATIENT HAD CLEAR OPIOID-INDUCED SIDE EFFECTS SUCH AS TIREDNESS, CONSTIPATION, AND DRY MOUTH. AS THE PATIENT HAD ALREADY PREVIOUSLY HAD CEREBROSPINAL FLUID LEAK SYNDROME AFTER A MYELOGRAM, THEY LOGICALLY ASSUMED CEREBROSPINAL FLUID LEAK SYNDROME AFTER THE PROCEDURE. THE TWO EPIDURAL BLOOD PATCHES EACH PRODUCED A SHOR T-TERM POSITIVE RESULT, ALTHOUGH IN HINDSIGHT THE PROBLEM OF THE CEREBROSPINAL FLUID LEAK WAS NOT LOCATED IN THIS AREA. BECAUSE, FOLLOWING THE MYELOGRAM SOME YEARS AGO, THE PATIENT WAS ONLY SYMPTOM FREE AFTER SECOND BLOOD PATCH WAS PERFORMED, THEY DECIDED ALSO TO PERFORM THE SECOND BLOOD PATCH. THE VOLUME OF THE EPIDURAL BLOOD PATCH WAS IN THE UPPER NORMAL RANGE AT 30¿50 ML. PATHOPHYSIOLOGICALLY, THE EPIDURAL AUTOLOGOUS BLOOD PATCH MUST HAVE CAUSED AN EPIDURAL PRESSURE INCREASE AND THEREFORE AN INCREASE IN THE CEREBROSPINAL FLUID PRESSURE. THIS IS THE ONLY WAY THE TRANSIENT IMPROVEMENT CAN BE EXPLAINED. AFTER 2 UNSUCCESSFUL BLOOD PATCHES AND CONSISTENT CONSERVATIVE THERAPY WITH FLUID REPLACEMENT, ANALGESIA AND CAFFEINE, THE SYMPTOMS PERSISTED. THE INITIAL IMPROVEMENT IN SYMPTOMS, WHICH PERSISTED FOR A LONGER PERIOD UNTIL THE SUTURES WERE REMOVED ON THE 12TH DAY AFTER THE PROCEDURE, CAN BE EXPLAINED BY THE FACT THAT THE CEREBROSPINAL FLUID COLLECTION IN THE TISSUE EXERTED A CERTAIN COUNTER PRESSURE IN THE SYSTEM AND THEREFORE THE AMOUNT OF CEREBROSPINAL FLUID LEAKAGE DECREASED FOR A TRANSIENT PERIOD. A PROBLEM WITH THE CATHETER WAS NOT INITIALLY CONSIDERED. THEY ASSUMED THAT THE FLUID BEING DISCHARGED FROM THE PARAVERTEBRAL REGION WAS DUE TO A POSTOPERATIVE SEROMA WHICH SPONTANEOUSLY DISCHARGED. WITH AN EXTERNAL CEREBROSPINAL FLUID LEAK OF THIS EXTENT, A SEVERE INCREASE IN PAIN AND WITHDRAWAL SYMPTOMS HAD TO BE EXPECTED, AS THE ADMINISTERED OPIOID WITH A DELIVERY RATE OF 1.5 ML PER DAY WOULD SURELY HAVE ALSO ESCAPED WITH THE LEAK. NO EVIDENCE COULD BE FOUND OF EITHER A DURAL LEAK OR A COLLECTION OF CEREBROSPINAL FLUID IN THIS AREA EITHER USING (MRI) IMAGING. WITH HINDSIGHT, IT WOULD HAVE BEEN POSSIBLE TO DETECT -2-TRANSFERRIN IN THE FLUID SECRETED FROM THE PARAVERTEBRAL AREA, WHICH HAS A HIGH SENSITIVITY AND SPECIFICITY FOR A CEREBROSPINAL FLUID LEAK. THE SPINAL CATHETER LEAK WAS IN THE AREA OF THE CATHETER FIXATION SITE ON THE MUSCLE FASCIA. DURING THE PROCEDURE, 2 FIXATION SUTURES WERE PLACED WHILE THE 14-G-TUOHY PUNCTURE NEEDLE WAS STILL IN SITU - THIS IS TO PREVENT THE CATHETER FROM BEING DAMAGED BY A NEEDLE. IT IS POSSIBLE THAT THE CATHETER WAS DAMAGED WHEN THE PUNCTURE NEEDLE AND CATHETER MANDREL WERE REMOVED. A FURTHER POSSIBILITY WORTH DISCUSSING WOULD BE A PRODUCTION DEFECT IN THE CATHETER, WHICH CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451755 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R