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

Model Number NEU_UNKNOWN_PUMP

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Muscular Rigidity (1968); Scarring (2061); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

It was not possible to match this event with any previously reported event.The main component of the system and other applicable components are: product id: neu_unknown_cath, serial# unknown, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Bakare a.A., weyhenmeyer j., lee, a.Subarachnoid to subarachnoid shunt for correction of nonfunctioning baclofen pump in a severe case of chronic debilitating post-spinal cord injury spasticity.World neurosurg.2018.110:26-29.Doi.Org/10.1016/j.Wneu.2017.10.127 summary: this (b)(6) paraplegic male with a t8 sci whose spasticity had been well managed with itb therapy for many years recently suffered intractable spasticity necessitating multiple reoperations for a nonfunctioning itb catheter secondary to extensive scar tissue and intrathecal adhesions.Placement of a subarachnoid-to-subarachnoid shunt eliminated the problem of extensive scar tissue preventing adequate baclofen therapy.Reported events: a (b)(6) male had a past medical history significant for paraplegia, neurogenic bowel and bladder, and chronic spasticity secon dary to severe traumatic brain injury and a t8 sci sustained in a motor vehicle accident.The patient¿s spasticity was previously well managed with intrathecal baclofen (itb) infusion for almost 20 years.His original intrathecal catheter entered the thecal sac at the l2-3 interspace and was threaded up to t10.Over the last 3 years, the patient presented to the neurosurgery clinic on several occasions with intractable torso and lower extremity spasticity.The persistent spasticity resulted in multiple operations for intrathecal catheter revision.Unfortunately, residual and increasing spasticity was not relieved by these interventions.During an itb catheter revision in early 2015, significant subarachnoid scarring was noted, which was preventing the intrathecal catheter from threading to the desired spinal level.Postoperatively, the patient continued to complain of disabling upper trunk spasticity in the area extending from the xyphoid to the shoulder.Given his persistent symptoms, they elected to pursue an additional operation 3 months later in an attempt to mitigate the increased spasticity.Before the operation there was concern that an intrathecal catheter extending from the lumbar spine would not be able to be threaded past the arachnoid adhesions and dural scar in the thoracic spine.With this in mind, they elected to perform bilateral laminectomies at t8 and t7, along with a partial laminectomy at t6, to facilitate direct placement of an intrathecal catheter in the thoracic spine.The intraoperative microscope was used to improve visualization to ensure that the catheter was not infiltrating the spinal cord parenchyma.The intraoperative microscope allowed for direct visualization of the old intrathecal catheter and arachnoid scar that had extended from the t8 level to the t9-10 level.They initially attempted to enter the thecal sac at the t8 spinal level and thread the intrathecal catheter rostral to the t6 level.Owing to the extensive scarring, they could not thread the intrathecal catheter higher than the t6 level; thus, they elected to place the catheter at t6 using fluoroscopic x-ray guidance and then ligated the old, nonfunctional lumbar catheter through a separate incision.Although the patient experienced some relief of spasms in the upper trunk area postoperatively, spasticity worsened in the lower extremities and abdominal area.The lower truncal spasticity was so bad that the patient frequently complained of worsening diarrhea-type symptoms with incomplete evacuation despite an adequate bowel regimen.The patient was started on bolus dosing of itb, 40 mg of oral baclofen daily, and large scheduled doses of oral valium.His high oral valium intake produced a significant cognitive decline.Unfortunately, however, his lower extremity symptoms persisted.The spasticity continued to be readily apparent on physical examination with lower extremity scissoring.Computed tomography myelography revealed a myelographic block impeding cerebrospinal fluid (csf) flow, and preventing the itb from providing adequate coverage in the lower extremities.Given the patient¿s persistent spasticity, 2 surgical options were discussed over several clinic visits: placement of a second baclofen pump with catheterization of the caudal intrathecal space, or a subarachnoid-to-subarachnoid shunting procedure with a shunt placed between the thoracic and lumbar spinal levels.After extensive consultation, the patient opted for the subarachnoid-tosubarachnoid shunting procedure.The patient was returned to the operating room in late 2016 for placement of the subarachnoid-to-subarachnoid shunt.The procedure began with a t4-5 laminectomy and an l2-3 laminectomy with intradural lysis of adhesions at both levels.Next, an intrathecal catheter was tunneled into the thecal sac at the l2-3 level.The baclofen catheter was then threaded rostrally from the lumbar laminectomy site up to the t11 vertebral level.A standard bactiseal antibiotic catheter was placed intradurally at the l2-3 and t4-5 laminectomy sites, creating a sub arachnoid-to-subarachnoid shunt.The shunt catheter was then split with scissors, and an inline low-pressure standard shunt valve was connected between the 2 catheters.The shunt was situated to provide an inferior-to-superior flow direction (e.G., lumbar to thoracic flow pattern).They elected to directly supply the lower thoracic spine with itb and shunt to the upper thoracic spine because the patient¿s lower trunk and leg symptoms were more difficult to deal with than his upper trunk symptoms.This allowed a baclofen gradient with a higher concentration of baclofen in the lower thoracic levels.Had the patient¿s symptoms had been reversed (i.E., worse spasticity in the upper extremities and thoracic regions), they would have placed the intrathecal catheter in the superior thoracic distribution and reversed the direction of csf flow on the shunt valve from superior to inferior.After the operation, the pump flow setting was decreased from 1700 mg/day to 700 mg/day.Postoperatively, the patient¿s spasticity was significantly improved the day after surgery and continued to improve during his hospitalization.He was monitored in the intensive care unit for 2 days, during which time his requirements for oral baclofen decreased substantially while his vital signs normalized.At his first postoperative clinic visit, the pump flow rate was further decreased to 496.6 mg, with continued control of his lower extremity and truncal symptoms.He was rapidly weaned off oral valium and now takes minimal oral baclofen as needed for spasticity.The patient was quite satisfied with his postoperative results.

• 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: 7267827
• MDR Text Key: 99951062
• Report Number: 3007566237-2018-00452
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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: 01/18/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 46 YR