BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3912401 · Received July 3, 2014

    Report

    Report Number
    3007566237-2014-01867
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    January 21, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT WAS NOT PROVIDED; THE GIVEN DATE REFLECTS THAT WHICH THE ARTICLE WAS ACCEPTED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    HUSTAK, E.C., ENGLE, M.P., VISWANATHAN, A., KOYYALAGUNTA, D. LUMBAR SUBARACHNOID HEMATOMA FOLLOWING AN EPIDURAL BLOOD PATCH FOR MENINGEAL PUNCTURE HEADACHE RELATED TO THE IMPLANTATION OF AN INTRATHECAL DRUG DELIVERY SYSTEM. PAIN PHYSICIAN. 2014; MAY/JUNE 2014; 17:E405-E411. SUMMARY: PERSISTENT MENINGEAL PUNCTURE HEADACHE (MPH) IS A KNOWN COMPLICATION FOLLOWING BOTH INTENTIONAL AND UNINTENTIONAL PUNCTURE OF THE DURA MATER. WE PRESENT A CASE OF PERSISTENT MPH FOLLOWING IMPLANTATION OF AN INTRATHECAL DRUG DELIVERY SYSTEM (IDDS). TWO SEPARATE EPIDURAL BLOOD PATCHES (EBP) WERE PERFORMED UNDER RADIOGRAPHIC GUIDANCE WITH CONTRAST VISUALIZATION OF THE EPIDURAL SPACE ON POSTOPERATIVE DAYS 16 AND 28, RESPECTIVELY. THE CASE WAS COMPLICATED BY THE DEVELOPMENT OF A SYMPTOMATIC LUMBAR SUBARACHNOID HEMATOMA DIAGNOSED ON POSTOPERATIVE DAY 35. THE PATIENT SUBSEQUENTLY UNDERWENT A LAMINECTOMY, EVACUATION OF THE HEMATOMA, AND EXPLANATION OF THE IDDS. THIS CASE ILLUSTRATES A POTENTIAL UNIQUE MORBIDITY ASSOCIATED WITH THE EBP IN A PATIENT WITH AN IDDS. THE REPORT CONCLUDES WITH A BRIEF REVIEW OF MPH FOLLOWED BY A DISCUSSION OF POSSIBLE MECHANISMS UNDERLYING THIS COMPLICATION. REPORTED EVENT: A (B)(6) CAUCASIAN MAN WAS REFERRED TO THE MD ANDERSON CANCER PAIN MANAGEMENT CENTER WITH A CHIEF COMPLAINT OF LEFT GROIN AND LOWER EXTREMITY PAIN. HIS PAIN SEQUELA WAS THE RESULT OF TREATMENT HE RECEIVED FOR ADENOCARCINOMA OF THE PROSTATE. SPECIFICALLY, HE UNDERWENT A ROBOTIC ASSISTED RADICAL PROSTATECTOMY UTILIZING A LEFT PARTIAL CAVERNOUS NERVE SPARING TECHNIQUE. FORTUNATELY, THE PATIENT HAD NO EVIDENCE OF PERSISTENT OR RECURRENT CANCER AT THE TIME OF OUR CONSULTATION. UNFORTUNATELY, THE PAIN, DESCRIBED STRICTLY IN NEUROPATHIC TERMS, SEVERELY LIMITED HIS ABILITY TO ENJOY AN ACTIVE LIFESTYLE. THE PATIENT FAILED EXTENSIVE ATTEMPTS AT MEDICATION MANAGEMENT WITH ANTI-CONVULSANTS, TRICYCLIC ANTIDEPRESSANTS, AND OPIOIDS. THE PAIN WAS ALSO REFRACTORY TO A LOCAL ANESTHETIC INJECTION TO THE PROSTATIC BED PERFORMED BY THE UROLOGIST UNDER TRANSRECTAL ULTRASOUND GUIDANCE. AFTER 9 MONTHS OF SUBOPTIMAL ORAL MEDICATION MANAGEMENT, ALTERNATIVE INTERVENTIONAL TECHNIQUES WERE PROPOSED INCLUDING A TRIAL OF SPINAL CORD STIMULATION AND/OR INTRATHECAL DRUG DELIVERY. THE PATIENT¿S HEALTH INSURANCE COMPANY DENIED A TRIAL OF SPINAL CORD STIMULATION AND, ULTIMATELY, THE PATIENT UNDERWENT AN INTRATHECAL TRIAL WITH ZICONOTIDE AND BUPIVACAINE. THE SINGLE SHOT INTRATHECAL TRIAL WAS PERFORMED UTILIZING A 25-GAUGE PENCIL POINT NEEDLE AT THE L3-4 INTERSPACE. THE DOSE DELIVERED WAS 3 MCG OF ZICONOTIDE AND 2 MG OF BUPIVACAINE. THE PATIENT REPORTED HIS PAIN RELIEF AS A ¿100% SUCCESS.¿ EVENTUALLY, HE WAS TAKEN TO THE OPERATING ROOM AND UNDERWENT AN UNCOMPLICATED IDDS I MPLANTATION WITH CATHETER INTRODUCTION THROUGH THE L2-L3 INTER-LAMINAR SPACE. THE CATHETER TIP WAS ADVANCED TO THE INFERIOR ASPECT OF THE T10 VERTEBRAL BODY. THE IDDS WAS SET TO DELIVER 1 MCG OF ZICONOTIDE AND 2 MG OF BUPIVACAINE DAILY. POST-OPERATIVELY HE AGAIN R EPORTED EXCEPTIONAL PAIN RELIEF AND WAS DISCHARGED HOME. ON POSTOPERATIVE DAY (POD) 7, THE PATIENT REPORTED A MILD POSTURAL HEADACHE ALONG WITH MILD WOUND TENDERNESS AND ERYTHEMA. HE WAS AFEBRILE AND NO MENINGEAL SIGNS WERE APPRECIATED. THE PATIENT WAS PROVIDED A PRESCRIPTION FOR ORAL ANTIBIOTICS AND INSTRUCTED TO INCREASE HIS ORAL INTAKE OF FLUIDS. THE TENDERNESS AND ERYTHEMA SUBSEQUENTLY RESOLVED AS DID THE HEADACHE. HOWEVER, ON POD 16 THE PATIENT REPORTED A SEVERE POSTURAL HEADACHE WITH THE ADDITIONAL COMPLAINT OF TINNITUS. HISTINNITUS WAS THOUGHT TO BE SECONDARY TO ZICONOTIDE SO HIS DOSE WAS DECREASED TO 0.7 MCG PER DAY. GIVEN THE SEVERITY OF HIS HEADACHE AND THE FACT THAT IT FULFILLED DIAGNOSTIC CRITERIA FOR A MPH, AN EBP WAS PERFORMED AT L5-S1 INTERSPACE, BELOW THE LEVEL OF THE LUMBAR INCISION USING RADIOGRAPHIC GUIDANCE. AN 18-GAUGE TUOHY NEEDLE WAS UTILIZED AND THE EPIDURAL SPACE WAS IDENTIFIED USING A STANDARD LOSS OF RESISTANCE TECHNIQUE. APPROPRIATE NEEDLE TIP POSITION IN THE EPIDURAL SPACE WAS CONFIRMED BY A LACK OF CSF RETURN FROM THE TUOHY NEEDLE AND BY RADIOGRAPHIC EVIDENCE OF EPIDURAL CONTRAST SPREAD. TWENTY ML OF AUTOLOGOUS BLOOD WAS THEN COLLECTED IN A STERILE FASHION AND INJECTED SLOWLY THROUGH THE NEEDLE. AFTER THE PROCEDURE, THE PATIENT REPORTED GOOD HEADACHE RELIEF. ON POD 23 HE REPORTED NEAR COMPLETE RESOLUTION OF HIS HEADACHE. FROM A FUNCTIONAL STANDPOINT, HE HAD RETURNED TO WORK AND WAS PLEASED WITH THE PROCEDURAL OUTCOME. ON POD 28 THE MPH AND TINNITUS RECURRED AND THE PATIENT RETURNED TO CLINIC FOR A REPEAT EBP. AN EBP WAS PERFORMED AT L4-L5 INTERSPACE UTILIZING AN IDENTICAL TECHNIQUE EXCEPT THAT AFTER THE EPIDURAL SPACE WAS IDENTIFIED, A CATHETER WAS ADVANCED JUST DISTAL TO THE EPIDURAL NEEDLE UP TO THE L2-L3 INTERSPACE LEVEL WITHIN THE EPIDURAL SPACE. ASPIRATION FROM THE CATHETER WAS NEGATIVE AND CONTRAST WAS AGAIN INJECTED, RADIOGRAPHICALLY DEMONSTRATING EPIDURAL SPREAD. TWENTY ML OF AUTOLOGOUS BLOOD WAS THEN SLOWLY INJECTED. TOWARD THE END OF THIS PROCEDURE, THE PATIENT FELT MILD PRESSURE BEHIND HIS EYES. THE NEXT DAY THE PATIENT WAS SENT FOR A NEUROLOGY CONSULTATION FOR HIS PERSISTENT TINNITUS. BY THE TIME HE WAS SEEN, HE EXPERIENCED SLIGHT RETURN OF MPH SYMPTOMS. A MAGNETIC RESONANCE IMAGING (MRI) SCAN OF HIS BRAIN WAS PERFORMED AND WAS UNREMARKABLE. ON POD 34, THE PATIENT PRESENTED TO THE MD ANDERSON EMERGENCY DEPARTMENT WITH INCREASING HEADACHE, LOW BACK PAIN, BILATERAL LOWER EXTREMITY RADICULAR PAIN, AND SUBJECTIVE COMPLAINTS OF URINARY RETENTION. A STAT MRI OF HIS LUMBOSACRAL SPINE WAS OBTAINED WHICH REVEALED A BLOOD COLLECTION WITHIN THE THECAL SAC AT THE L4-L5 LEVEL. A NEUROSURGICAL CONSULTATION WAS OBTAINED, AND GIVEN THE PATIENT¿S SUBJECTIVE ASSESSMENT THAT HIS SYMPTOMS WERE WORSENING, THE DECISION WAS MADE TO OFFER SURGICAL EXPLORATION. ON POD 35 THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR AN L4 AND L5 LAMINECTOMY, EVACUATION OF A SUBARACHNOID HEMATOMA, AND EXPLANTATION OF THE IDDS. THE DURA WAS CLOSED WITH SILK SUTURES ALONG WITH APPLICATION OF DURASEAL; COVIDIEN, MANSFIELD, MA). NO SIGNS OF SUPERFICIAL OR DEEP SURGICAL SITE INFECTIONS WERE IDENTIFIED. THE PATIENT WAS DISCHARGED HOME WITHOUT MPH SYMPTOMS. HIS ORIGINAL LOWER EXTREMITY AND GROIN NEUROPATHIC PAIN COMPLAINTS SUBSEQUENTLY RETURNED AND HE WAS AGAIN MANAGED PHARMACOLOGICALLY WITH ANTI-CONVULSANTS, TRICYCLIC ANTIDEPRESSANTS, AND OPIOID THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391522 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention