BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    MDR report key: 5884417 · Received August 17, 2016

    Report

    Report Number
    3007566237-2016-02974
    Event Type
    Injury
    Date Received
    August 17, 2016
    Date of Event
    February 1, 2016
    Report Date
    August 17, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. 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

    CHAE, Y.J., HAN, K.R., PARK, H.B., KIM, C., NAM, S.G. PARAPLEGIA FOLLOWING CERVICAL EPIDURAL CATHETERIZATION USING LOSS OF RESISTANCE TECHNIQUE WITH AIR: A CASE REPORT. KOREAN JOURNAL OF ANESTHESIOLOGY. 2016. 69(1):66-70. DOI: 10.4097/KJAE.2016.69.1.66 SUMMARY: WE REPORT A CASE OF PARAPLEGIA WITHOUT NEUROLOGIC DEFICIT OF UPPER EXTREMITIES FOLLOWING CERVICAL EPIDURAL CATHETERIZATION USING AIR DURING THE LOSS OF RESISTANCE TECHNIQUE. A (B)(6) WOMAN DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME HAD UPPER AND LOWER EXTREMITY PAIN. A THORACIC EPIDURAL LEAD WAS INSERTED FOR A TRIAL SPINAL CORD STIMULATION FOR TREATING LOWER EXTREMITY PAIN AND CERVICAL EPIDURAL CATHETERIZATION WAS PERFORMED FOR TREATING UPPER EXTREMITY PAIN. RAPIDLY PROGRESSIVE PARAPLEGIA DEVELOPED SIX HOURS AFTER CERVICAL EPIDURAL CATHETERIZATION. SPINE CT REVEALED AIR ENTRAPMENT IN MULTIPLE THORACIC INTERVERTEBRAL FORAMINAL SPACES AND SURROUNDING EPIDURAL SPACE WITHOUT OBVIOUS SPINAL CORD COMPRESSION BEFORE THE DECOMPRESSIVE OPERATION, WHICH DISAPPEARED ONE DAY AFTER THE DECOMPRESSIVE OPERATION. HER PARAPLEGIA SYMPTOMS WERE NORMALIZED IMMEDIATELY AFTER THE OPERATION. THE PRESUMED CAUSE OF PARAPLEGIA WAS TRANSIENT INTERRUPTION OF BLOOD SUPPLY TO THE SPINAL CORD THROUGH THE SEGMENTAL RADICULOMEDULLARY ARTERIES FEEDING THE SPINAL CORD AT THE THORACIC LEVEL OF THE INTERVERTEBRAL FORAMEN CAUSED BY THE AIR. REPORTED EVENTS: ONE (B)(6) FEMALE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) TRIAL IN THE LOWER THORACIC AREA FOR TREATMENT OF LOWER EXTREMITY PAIN DUE TO COMPLEX REGIONAL PAIN SYNDROME (CRPS); THE PATIENT THEN UNDERWENT CERVICAL EPIDURAL CATHETERIZATION WITH A 20-GAUGE CATHETER THROUGH AN 18-GAUGE TUOHY NEEDLE AT C7-T1 FOR TREATMENT OF UPPER EXTREMITY PAIN DUE TO CPRS. SHE WAS COMFORTABLE AND ABLE TO AMBULATE IN THE IN-PATIENT WARD AFTER CERVICAL EPIDURAL CATHETERIZATION. SIX HOURS AFTER INSERTION OF THE CERVICAL EPIDURAL CATHETER, SHE SUDDENLY COMPLAINED OF HYPOESTHESIA AND MOTOR WEAKNESS OF BOTH LOWER EXTREMITIES. NEUROLOGIC ASSESSMENT REVEALED MARKEDLY DECREASED SENSATION TO PINPRICK, COLD, AND TOUCH BELOW THE T10 DERMATOME AND SLIGHT CONTRACTION OF THE LEG AND FOOT MUSCLES WITHOUT MOVEMENT (GRADE 1/5). THE AUTHORS SUSPECTED AN EPIDURAL HEMATOMA AROUND THE THORACIC SPINE POSSIBLY RELATED TO THE PREVIOUS EPIDURAL PROCEDURES AND CONSIDERED WHOLE SPINE MRI ALTHOUGH SHE DID NOT HAVE TYPICAL PAIN ACCOMPANYING AN EPIDURAL HEMATOMA. HOWEVER, SHE UNDERWENT A WHOLE SPINE CT AS SHE HAD RECEIVED AN SCS TRIAL LEAD. DEFINITIVE FINDINGS OF WHOLE SPINE CT SCAN WERE MULTIFOCAL AIR DENSITIES IN THE EPIDURAL SPACE, INTERVERTEBRAL FORAMEN, AND PARASPINAL MUSCLES BETWEEN C1 AND T9 AND NO OBVIOUS SPINAL CORD COMPRESSION. WHILE EVALUATING THE PATIENT AND PERFORMING CT SCAN, WITHIN ONE HOUR, THE SENSATION BELOW THE T10 DERMATOME WAS TOTALLY ABSENT AND MUSCLE POWER OF BOTH LOWER EXTREMITIES WAS ZERO WITH NO CONTRACTION (0/5). WHEN THE AUTHORS EXAMINED THE PATIENT IMMEDIATELY AFTER SHE DEVELOPED PARAPLEGIA, THEY PRESUMED THE CAUSE WAS DELAYED EPIDURAL HEMATOMA OR ABSCESS THAT DEVELOPED THREE DAYS AFTER THE PLACEMENT OF THE THORACIC EPIDURAL SCS TRIAL LEAD, OR EPIDURAL HEMATOMA OR SPINAL CORD ISCHEMIA RELATED TO CERVICAL EPIDURAL CATHETERIZATION SIX HOURS BEFORE THE PARAPLEGIA DEVELOPED. A NEUROSURGEON WAS CONSULTED FOR EMERGENT DECOMPRESSIVE SURGERY ALTHOUGH THERE WAS NO OBVIOUS SPINAL CORD COMPRESSION DUE TO A MASS-LIKE LESION SUCH AS EPIDURAL HEMATOMA OR ABSCESS. WITHIN THREE HOURS AFTER THE PARAPLEGIA DEVELOPED, DECOMPRESSIVE OPERATION WAS STARTED BY TARGETING THE INSERTION SITE OF THE TRIAL SCS ELECTRODE AT THE LOWER THORACIC SPINE FIRST BECAUSE THE NEUROLOGIC DEFICIT DEVELOPED BELOW THE T10 LEVEL. HOWEVER, THERE WAS NO HEMATOMA OR ABNORMAL FINDINGS IN THE EPIDURAL SPACE WHERE THE TRIAL SCS ELECTRODE WAS PLACED AT T9-T12. THE RADIOLOGIST AND THE AUTHORS THOUGHT THAT MULTIFOCAL AIR COLLECTION IN THE EPIDURAL SPACE AND INTERVERTEBRAL FORAMEN COULD BE THE CAUSE OF PARAPLEGIA, AND A DECOMPRESSIVE OPERATION IN THE CERVICAL SPINE WAS PERFORMED IMMEDIATELY AFTER THE CLOSURE OF THE THORACIC SPINE. AS SOON AS THE CERVICAL EPIDURAL SPACE WAS OPENED, THE NEUROSURGEON NOTICED ESCAPE OF AIR BUBBLES WITH THE NAKED EYE AND THERE WAS NO HEMATOMA OR ANY OTHER LESION. IMMEDIATELY AFTER THE DECOMPRESSIVE SURGERY, THE PATIENT UNDERWENT WHOLE SPINE MRI FOR EVALUATION OF THE SPINAL CORD AND EPIDURAL SPACE. THERE WERE NO FINDINGS OF SPINAL CORD ISCHEMIA ON THE WHOLE SPINE MRI. HER SENSATION AND MOTOR FUNCTION RECOVERED TO NORMAL IMMEDIATELY AFTER SHE AWOKE IN POST-ANESTHESIA CARE UNIT. THE FOLLOWING DAY, WHOLE SPINE CT WAS PERFORMED AND IT REVEALED NEARLY COMPLETE DISAPPEARANCE OF EPIDURAL AND PARAVERTEBRAL AIR. THERE WAS AN IMMEDIATE AND COMPLETE RECOVERY OF THE NEUROLOGICAL DEFICIT. ONE MONTH AFTER THIS INCIDENT, THE PATIENT UNDERWENT PERMANENT SCS FOR MANAGEMENT OF PAIN IN THE LOWER EXTREMITIES. THE PRESUMED CAUSE OF THE PARAPLEGIA WAS TRANSIENT INTERRUPTION OF BLOOD SUPPLY TO THE SPINAL CORD THROUGH THE SEGMENTAL RADICULOMEDULLARY ARTERIES FEEDING THE SPINAL CORD AT THE THORACIC LEVEL OF THE INTERVERTEBRAL FORAMEN CAUSED BY THE AIR. THE AUTHOR CONCLUDED THAT CERVICAL EPIDURAL PROCEDURES CAN CAUSE PARAPLEGIA WITHOUT NEUROLOGIC DEFICIT OF THE UPPER EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535142 EXTERNAL NEUROSTIMULATOR, UNKNOWN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention