Arizona – Orthopedic Surgery – Complications After Spinal Cord Stimulator Placement

A 45-year-old man was referred to orthopedic spinal surgery for chronic cervical pain.  He had undergone spinal surgery in 2005.

On 07/24/2006, the orthopedic spinal surgeon saw the patient.  He noted that the patient complained of left and right upper extremity pain.  Examination revealed weakness of the patient’s left arm with no upper motor neuron signs.  The orthopedic spinal surgeon did not think that the patient was a candidate for surgery and recommended a spinal cord stimulator.

On 08/16/2006, the orthopedic spinal surgeon performed surgery to place a spinal cord stimulator.  He documented a laminectomy at C3-C5 with placement of a spinal cord stimulator.

On 08/28/2005, the orthopedic spinal surgeon noted that the patient was “getting excellent left arm pain relief right now, but states that his right arm is absolutely ‘killing him.’”  The orthopedic spinal surgeon noted that an x-ray showed that the spinal cord stimulator lead was a “little bit off to the right in the upper cervical spine.”  Because “lead placement should be excellent,” the orthopedic spinal surgeon arranged to meet with the stimulator’s manufacturer.  The orthopedic spinal surgeon noted that the patient’s neurological examination was the same.

On 09/01/2006, the orthopedic spinal surgeon performed a second surgery for revision of the spinal cord stimulator.  He noted that he attempted to position the lead on the stimulator at least 30 times and that subsequently the paddle lead broke.  The orthopedic spinal surgeon attributed his difficulty in placing the stimulator to a defect in the paddle.

A Medical Consultant to the Board, who was one of the orthopedic spinal surgeon’s partner, testified that 30 attempts to position the lead on the stimulator was excessive.  He also testified that it was quite common for a surgeon to experience difficulty in placing the paddle and possible for a surgeon to make 30 attempts.

The orthopedic spinal surgeon noted that the patient was neurologically intact upon awakening.  A progress note by a medical assistant dated 09/02/2006 noted that the patient was intact neurologically and could be discharged.

The orthopedic spinal surgeon testified at the hearing that he had positioned the spinal cord stimulator over the patient’s cervical dura at C4, C4 to mask the patient’s symptoms.

In an office note dated 09/01/2006, the orthopedic spinal surgeon that he “had to reposition the stimulator because it was a little too close to his right cervical nerve root C4 and C4.”  No neurological exam was recorded.

The orthopedic spinal surgeon’s subsequent office note dated 09/13/2006 noted that the patient’s wound was healing well, the paddle was in excellent position, and the patient’s right arm pain was slowly diminishing.  The orthopedic spinal surgeon placed the patient on a Medrol Dosepack for the residual right arm symptoms.  No neurological examination was documented.

On 10/23/2006, the orthopedic spinal surgeon noted that the patient had increased pain since he had started physical therapy.  The orthopedic spinal surgeon advised the patient to stop the physical therapy.  The orthopedic spinal surgeon noted that the patient was neurologically intact except for numbness of the right hand.  The orthopedic spinal surgeon noted the patient’s prior diagnosis of carpal tunnel syndrome, expressed concern about a double crush syndrome, and placed the patient’s right arm in a splint.

On 11/02/2006, the patient’s partner saw the patient and documented that the patient had more pain with the spinal cord stimulator on than off and appeared myelopathic with a Hoffman’s sign of the right upper extremity, had 3 beats of clonus in the lower extremities, and had weakness of the right upper extremity.  He recommended an MRI scan and removal of the spinal cord stimulator.

On 11/20/2006, the orthopedic spinal surgeon removed the spinal cord stimulator that he had previously implanted in the patient.  On the pre-surgical physical, he recorded no nerve deficits.  The orthopedic spinal surgeon documented his removal of the spinal cord stimulator and noted that as he pulled it, some of the titanium sensors came off.  He accounted for finding 15 of the 16 titanium beads.

An MRI of the patient dated 12/12/2006 recorded a signal alteration in the posterior cord at C3-C4 and C4-C5 with a somewhat cystic appearance at C4-C5.  It was noted that this was not seen in prior studies and may have indicated a myelomalacia.  Also noted was the central disc protrusion at C4-C4 and a right paracentral disc protrusion at C4-C5, which appeared unchanged.

The orthopedic spinal surgeon transferred the patient to his partner, who on 12/15/2006, noted that the patient had significant pain of the right upper extremity with some gait abnormalities and clumsiness of the right upper extremity.  The partner noted that the patient’s MRI scan evidenced myelomalacia at C4-C4 and C4-C5 and recommended a surgical decompression.

On 12/27/2006, another surgeon consulted on the patient’s case.  He recommended an anterior discectomy at C3-C4, C4-C5, and plate removal at C5-C6 for cervical spondylosis with cord compression and a myelopathy at C3-C4 and C4-C5.  This was completed on 02/22/2007.

The patient was seen by a neurologist on 05/22/2007.  He diagnosed the patient with chronic pain syndrome and cervical radiculopathy post cervical spine surgery.  The patient has been under the care of a physician for pain management since March 2007.

The orthopedic spinal surgeon testified that the signal intensity at C4-C5 was below where he placed the spinal cord stimulator at C2.

A Medical Consultant of the Board, a partner of the orthopedic spinal surgeon who had performed the initial surgery, noted that the patient was doing well until physical therapy and that the MRI demonstrated that the patient’s myelomalacia was a progression of his underlying condition, not due to placement of the spinal cord stimulator.  The patient had severe spinal stenosis that progressed and impingement of the cord from the front and back.  He explained that the cystic changes on the MRI were below the location of the surgery and that the architectural changes in the patient’s spine (front and back) most likely caused the signal changes.

Another Medical Consultant’s investigative report to the Board noted that “[t]here is a very high adverse event rate in spinal cord stimulator procedures reported in various studies between 30% and 75%.”

The Board judged the orthopedic spinal surgeon’s conduct to be below the minimum standard of competence given failure to perform the procedure in a manner to avoid injury to the spinal cord.  Neurological examinations were not documented.  Appropriate diagnostic studies were not performed when the patient had a change in neurological condition.  He did not document in his operative report the level at which he placed the paddle after 30 attempts.  The Board, however, acknowledged that they did not establish that the orthopedic spinal surgeon caused actual harm to the patient.

The Board reviewed complications of this case among many others that involved the orthopedic spinal surgeon.  They remained concerned that the orthopedic spinal surgeon continued to insist that he made no mistakes in the care of his patients despite being confronted with the evidence.  The Board ultimately ordered his license to be revoked.

State: Arizona

Date: February 2009

Specialty: Orthopedic Surgery

Symptom: Extremity Pain, Pelvic/Groin Pain, Weakness/Fatigue

Diagnosis: Post-operative/Operative Complication, Spinal Injury Or Disorder

Medical Error: Procedural error, Failure to order appropriate diagnostic test, Lack of proper documentation

Significant Outcome: N/A

Case Rating: 3

Link to Original Case File: Download PDF

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