MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE INFUSION PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number NEU_UNKNOWN_PUMP

Device Problem Difficult to Advance (2920)

Patient Problems Erythema (1840); Unspecified Infection (1930); Muscle Weakness (1967); Paresis (1998); Spinal Cord Injury (2432); Decreased Sensitivity (2683)

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_cath, product type: catheter.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.

Event Description

Slavin, k.V.Intramedullary placement of intrathecal catheter.Report of a rare complication of intrathecal therapy.Journal of the international neuromodulation society.2006.9(2):94-99.Summary: a rare complication of intrathecal drug therapy¿inadvertent insertion of the intrathecal catheter into the matter of the spinal cord¿is presented.The patient developed signs of progressive monoparesis immediately after implantation of an intrathecal drug delivery system.The underlying problem was diagnosed with computed tomographic (ct) myelography and magnetic resonance imaging.The symptoms resolved after the catheter was removed.The article discusses probable mechanism of the complication and possible ways of its prevention.The usefulness of ct myelography in determining the intrathecal catheter position relative to the spinal cord is emphasized.Reported events: this (b)(6) severely obese woman presented to a pain specialist at an outside facility with severe diffuse pain primarily involving her lower back and both legs, as well as one of her arms.The pain had begun after the patient was assaulted and injured several years earlier.The clinical diagnosis of chronic pain, most likely to spondylosis, was made although imaging did not show any signs of degenerative spine disease.She had failed multiple medication regimens in the past, and had gradually advanced to a combination of opioid and nonopioid management, including fentanyl patches, oral hydrocodone¿acetaminophen combination for breakthrough pain, several muscle relaxants, and amitriptyline.Since she required a relatively high dose of oral and transcutaneous opioids, her pain physician suggested trying intraspinal opioid delivery.A 1-week trial of epidural morphine administration was successful in decreasing the pain intensity to less than half of the baseline level; this was considered a satisfactory indication for implantation of an intrathecal catheter and a programmable pump for continuous morphine infusion.According to the operative report from an outside medical facility, a standard intrathecal catheter was inserted at the t11¿t12 level and then advanced up to the t7 level with the patient under general anesthesia and in the lateral decubitus position.The catheter was then tunneled subcutaneously and connected to a programmable pump that was placed above the fascia in the left upper abdominal quadrant.The surgery was uneventful, but soon after awakening from anesthesia the patient complained of right foot weakness.This was interpreted as a sign of radicular irritation and the patient was discharged home after morphine infusion using the pump was started.The weakness, however, gradually progressed during the first postoperative week to a pronounced right lower monoparesis.She was therefore admitted to another institution, where she was noted to have a mild sensory loss in both lower extremities and the perineal area, with a sensory level starting at approximately the t8 dermatome.Physical examination revealed some redness over the lumbar area that was considered as a possible superficial wound infection, but there was no tenderness along the catheter tract or around the pump site.Thoracolumbar spine x-rays showed the intrathecal catheter inside the spinal canal with the catheter tip at the level of the t7 vertebral body (fig.1).Since the clinical picture was unclear, a magnetic resonance imaging (mri) study was performed.It revealed a round lesion in the anterolateral quadrant of the spinal cord at the t7 level that appeared dark on all pulse sequences (fig.2).A radiologist interpreted this finding as a possible flow void or calcification within the spinal cord.There was no contrast enhancement of the lesion.To clarify the problem further, a computed tomography (ct) myelogram was performed, which revealed the intramedullary position of the catheter entering the spinal cord at the t11¿t12 level, and the catheter tip at the t7 level (fig.3).At this point, the morphine infusion was stopped and the patient was transferred to our institution.Her neurologic examination showed a right lower monoparesis (2¿3,5), no evidence of alteration in vibratory sensation, and somewhat decreased tactile and pinprick sensation in the t8 and t9 dermatomes on the right.Lower extremity reflexes were asymmetric (the right side less active than the left).Muscle tone in the right leg was decreased.There were no pathologic reflexes or clonuses.The patient had normal sphincter tone, but her postvoid residual volume of urine was 130 ml.Due to worsening of peri-incisional redness and concern about underlying infection, we decided to remove the entire infusion system instead of originally planned removal of the catheter alone.The steroids were not used due to the concern of possible worsening of suspected infection.During the surgery, the catheter and pump were removed uneventfully.The cultures from the wound were negative, and the patient was discharged home after an empiric course of antibiotics was completed and the lumbar incision h ad begun to show signs of secondary healing.With physical therapy, the patient¿s monoparesis improved significantly, and she was discharged home able to ambulate with only minimal assistance.Since the patient¿s symptoms progressed over 7¿10 days after the catheter insertion, we speculate that the continuous intramedullary infusion of morphine during that time contributed to the worsening of the clinical picture.Once the infusion was stopped and the catheter was removed, the neurologic deficits gradually resolved.The authors indicated the case was of an acute myelopathy caused by an inadvertent intraparenchymal placement of an intrathecal catheter.

• Brand Name: IMPLANTABLE INFUSION PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6803509
• MDR Text Key: 83012106
• Report Number: 3007566237-2017-03359
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR