MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Pain (1994); Tachycardia (2095)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the average age of the patients who underwent the tg procedure as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the tg procedure as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the published online date.The article citation is included.The system product number and serial number were not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Texakalidis, p., tora, m.S., mcmahon, j.T., greven, a., anthony, c.L., nagarajan, p., campbell, m., <(>&<)>amp; boulis, n.M.(2020).Percutaneous trigeminal stimulation for intractable facial pain: a case series.Neurosurgery, 87(3), 547¿554.Https://doi.Org/1 0.1093/neuros/nyaa065 summary: background: facial pain syndromes can be refractory to medical management and often need neurosurgical interventions.Neuromodulation techniques, including percutaneous trigeminal ganglion (tg) stimulation, are reversible and have emerged as alternative treatment options for intractable facial pain.Objective: to report the complication rates and analgesic effects associated with tg stimulation and identify potential predictors for these outcomes.Methods: a retrospective chart review of 59 patients with refractory facial pain who underwent tg stimulation was conducted.Outcomes following trial period and permanent stimulation were analyzed.Patients with >50% pain relief during trial stimulation received permanent implantation of the stimulation system.Results: successful trial stimulation was endorsed by 71.2% of patients.During the trial period, 1 tg lead erosion was identified.History of trauma (facial/head trauma and oral surgery) was the only predictor of a failed trial compared to pain of idiopathic etiology (odds ratio: 0.15; 95% ci: 0.03-0.66).Following permanent implantation, approximately 29.6% and 26.5% of patients were diagnosed with lead erosion and infection of the hardware, respectively.Tg lead migrations occurred in 11.7% of the patients.The numeric rating scale score showed a statistically significant reduction of 2.49 (95% ci: 1.37-3.61; p =.0001) at an average of 10.8 mo following permanent implantation.Conclusion: tg stimulation is a feasible neuromodulatory approach for the treatment of intractable facial pain.Facial/head trauma and oral surgery may predict a nonsuccessful trial stimulation.Future development of specifically designed electrodes for stimulation of the tg, and solutions to reduce lead contamination are needed to mitigate the relatively high complication rate.Reported events: fifty-nine patients with a histology of a facial pain syndrome underwent a trial tg stimulation and potentially simultaneous supraorbital nerve simulation and/or infraorbital nerve stimulation.Of these fifty-nine patients, it was reported that five patients experienced exacerbation of their facial pain, one patient suffered exacerbation of congestive heart failure, and there was one report of a cerebrospinal fluid(csf) leak, which was successfully managed with placement of a superficial suture.Thirty-five of the fifty-nine patients then underwent the permanent implantation of a tg stimulation system.Nine cases of infection were found; six and three infections were diagnosed in the retro-auricular/temple space and the internal pulse generator, respectively.The infections were managed with explanation of the stimulation system.See attached article.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12594392
• MDR Text Key: 275375168
• Report Number: 1723170-2021-02458
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR