BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 7809743 · Received August 23, 2018

    Report

    Report Number
    3007566237-2018-02518
    Event Type
    Injury
    Date Received
    August 23, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WANG, D., QURESHI, M., SMITH, J., KHETANI, N. SPINAL CORD COMPRESSION RELATED TO SPINAL CORD STIMULATOR. PAIN MED. 2018. 19(1): 212-214. DOI: 10.1093/PM/PNX123 SUMMARY: THERE IS VERY LITTLE PUBLISHED DATA ON THE RARE BUT SERIOUS COMPLICATION OF SPINAL CORD COMPRESSION ASSOCIATED WITH SPINAL CORD STIMULATOR (SCS) PLACEMENT. WE RECENTLY ENCOUNTERED A COMPELLING CASE IN WHICH A PATIENT DEVELOPED SUBTLE SIGNS OF SPINAL CORD COMPRESSION AFTER SCS PLACEMENT. THIS PATIENT IS A VERY PLEASANT (B)(6) LADY WHO WAS REFERRED BY HER NEUROSURGEON TO CONSIDER AN SCS TRIAL. SHE HAS A HISTORY OF LUMBAR RADICULOPATHY AND SPINAL STENOSIS. SHE UNFORTUNATELY SUFFERS SEVERE PERSISTENT PAIN IN THE LOWER EXTREMITIES DESPITE EXTENSIVE CONSERVATIVE TREATMENTS. THE PATIENT ELECTED TO HAVE AN SCS TRIAL BEFORE CONSIDERING SURGICAL DECOMPRESSION. HER PE PRIOR TO SCS TRIAL REVEALED AN ANTALGIC GAIT AND AMBULATION WITH A SINGLE POINT CANE. MOTOR STRENGTH TESTING WAS 5/5 IN THE LOWER EXTREMITIES THROUGHOUT. PROPRIOCEPTION, PIN-PRICK, AND LIGHT TOUCH SENSATION WERE INTACT IN THE LOWER EXTREMITIES. THE SCS TRIAL WAS UNEVENTFUL WITH TWO PERCUTANEOUS MEDTRONIC OCTRODE SPINAL CORD STIMULATORS POSITIONED AT THE T8 LEVEL. THE INSERTION LEVEL FOR THE PERCUTANEOUS LEADS WAS AT THE L1-L2 INTERLAMINAR SPACE. SHE REPORTED GREATER THAN 50% RELIEF DURING THE FIVE-DAY TRIAL PERIOD. THE PERMANENT SCS SYSTEM WAS IMPLANTED THREE WEEKS LATER. HER PAIN PATTERN AND PE WERE UNCHANGED BEFORE THE PERMANENT STIMULATOR IMPLANTATION. THE PERMANENT SCS PROCEDURE WAS PERFORMED IN THE SAME FASHION WHILE THE PATIENT WAS IN A PRONE POSITION WITH EPIDURAL NEEDLE ENTRY SITES AT THE L1-L2 INTERLAMINAR SPACE. A MAGNETIC RESONANCE IMAGING (MRI)¿COMPATIBLE PULSE GENERATOR AND TWO PERCUTANEOUS SPINAL CORD STIMULATORS WERE IMPLANTED WITH FINAL LEAD PLACEMENT AT THE T8 LEVEL. ADEQUATE STIMULATION COVERAGE IN THE LOWER BACK AND BOTH LOWER EXTREMITIES WAS CONFIRMED DURING INTRAOPERATIVE PROGRAMING. POSTOPERATIVELY, SHE DENIED ANY WORSENING PAIN, WEAKNESS IN THE LEGS, OR PAIN IN THE THORACIC BACK REGION. HOWEVER, SHE WAS FOUND UNABLE TO STAND OR AMBULATE WITHOUT ASSISTANCE. THERE WAS NO SWELLING OR HEMATOMA AT THE SURGICAL SITES. MOTOR STRENGTH IN SITTING POSITION REVEALED HIP FLEXORS 4/5, KNEE EXTENSORS 4/5, DORSIFLEXORS AND EXTENSOR HALLUCIS LONGUS 5/5. SENSORY EXAM REVEALED INTACT PIN-PRICK AND LIGHT TOUCH OF THE ENTIRE LOWER LIMBS. FURTHER EXAM REVEALED ABSENT PROPRIOCEPTION AT THE BILATERAL DISTAL INTERPHALANGEAL JOINTS OF THE GREAT TOES AND ABSENT VIBRATORY SENSATION AT THE BILATERAL LATERAL MALLEOLI. AN EMERGENCY THORACOLUMBAR MRI WAS ORDERED. HOWEVER, THE RADIOLOGIST REFUSED TO P ERFORM THIS MRI DESPITE DOCUMENTATION OF MRI COMPATIBILITY AS MEDTRONIC SCS WAS PROVIDED. BECAUSE ABSENT PROPRIOCEPTION AND VIBRATION SENSATION SUGGESTED POSSIBLE POSTERIOR SPINAL CORD COMPRESSION FROM SPINAL CORD STIMULATORS OR EPIDURAL HEMATOMA, THE SCS SYSTEM WAS PROMPTLY REMOVED. FORTUNATELY, THE MRI OBTAINED AFTER REMOVAL OF THE SCS SYSTEM REVEALED NO SIGNS OF SPINAL CORD INJURY, ONLY SEVERE STENOSIS AT THE T12-L1 LEVEL (FIGURES 1 AND 2). ON POSTOPERATIVE DAY (POD) 1, THE PATIENT WAS ABLE TO AMBULATE INDEPENDENTLY WITH A ROLLING WALKER. HER PROPRIOCEPTION BECAME INTACT IN THE LOWER EXTREMITIES. HER PHYSICAL EXAM FINDINGS RETURNED TO BASELINE ON POD 7. REPORTED EVENTS: AN 82 YEAR OLD FEMALE PATIENT DEVELOPED SUBTLE SIGNS OF SPINAL CORD COMPRESSION AFTER SCS PLACEMENT. THE PATIENT HAD A HISTORY OF LUMBAR RADICULOPATHY AND SPINAL STENOSIS. SHE UNFORTUNATELY SUFFERS SEVERE PERSISTENT PAIN IN THE LOWER EXTREMITIES DESPITE EXTENSIVE CONSERVATIVE TREATMENTS. POSTOPERATIVELY THE PATIENT WAS FOUND UNABLE TO STAND OR AMBULATE WITHOUT ASSISTANCE. THE SCS SYSTEM WAS PROMPTLY REMOVED. THE PATIENT WAS ABLE TO AMBULATE INDEPENDENTLY WITH A ROLLING WALKER. HER PROPRIOCEPTION BECAME INTACT IN THE LOWER EXTREMITIES. HER PHYSICAL EXAM FINDINGS RETURNED TO BASELINE ON POD 7. THIS RAISED OUR SUSPICION OF EPIDURAL HEMATOMA AND POSSIBLE SPINAL CORD COMPRESSION. IT APPEARED THAT EPIDURAL HEMATOMA WAS UNLIKELY DUE TO LACK OF THORACIC BACK PAIN OR INCREASED PAIN IN THE LOWER BACK AND LEGS. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649600 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention