BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    MDR report key: 5884399 · Received August 17, 2016

    Report

    Report Number
    3007566237-2016-02973
    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. 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). HER LOWER EXTREMITY PAIN SCORE DECREASED MODERATELY FROM 9 TO 5 ON THE VISUAL ANALOG SCALE (VAS). HOWEVER, ON THE THIRD DAY OF THE TRIAL, SHE WAS STILL SUFFERING FROM UPPER EXTREMITY PAIN (ALSO DUE TO CRPS) AND HER UPPER EXTREMITY PAIN SCORE WAS INCREASED FROM 7 TO 9 ON THE VAS DESPITE ORAL ANALGESICS AND INTERMITTENT INTRAVENOUS OPIOID RESCUE MEDICATION. CERVICAL EPIDURAL CATHETERIZATION WAS PLANNED FOR CONTINUOUS ADMINISTRATION OF ANALGESICS TO MANAGE HER UPPER EXTREMITY PAIN. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534513 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