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

Model Number UNK_NAV_SYS

Device Problem Imprecision (1307)

Patient Problems Dysphasia (2195); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: unk_nav_comp, version: (b)(4) unk_nav_comp represents the navigation software, framelink (b)(4).Patient information was not included in the journal entry.Age/date of birth: this value reflects the median age of the patients who underwent the electrode placement as specific patients could not be identified.Sex: this value reflects the majority gender of the patients who underwent the electrode placement as specific patients could not be identified.Date of event: 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.(b)(6).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

Rajesh alugolu, swapnil kolpakwar, vijayasaradhi mudumba, abhishek arora, rukmini kandadai, rupam borgohain.Prospective analysis of gross and fine motor manifestations following stn- dbs and their correlation with electrode position.Doi: 10.23736/s0390-5616.21.05461-8 summary background: deep brain stimulation (dbs) has been proven to be a safe, reversible, cost effective procedure for treatment of parkinson's disease.Final electrode position remains a significant factor determining the outcomes of subthalamic nucleus deep brain stimulation (stn-dbs).This study aims to analyze the final lead position in three-dimensional plane and its effect on gross and fine motor outcomes in cases of advanced parkinson's disease operated for stn-dbs.Methods: patients who underwent bilateral stn dbs were prospectively followed for improvement in gross motor outcomes at 6 months.Improvement in dysgraphia was analyzed by fahn-tolosa-marin tremor rating scale part b score.Postoperative outcomes were correlated with final electrode position.Results: a total of 64 patients (128 leads) were analyzed.Patients who were less than 65 years of age at time of surgery had more significant reduction in updrs iii(p = 0.02).Cases with deviation of left x less than 3 mm had significant reduction in updrs iii (p = 0.05) and speech sub-scores (p = 0.05).Deviation less than 2 mm in left x was associated with reduction in gait sub-scores (p = 0.04).Optimal placement of right y electrode was associated with reduction in updrs iii (p = 0.02).Significant reduction in fahn-tolosa-marin tremor rating scale part b score was noted after dbs(p =0.001).Conclusions: subthalamic nucleus deep brain stimulation thus results in significantly improved functional outcome particularly in patients with age less than 65 years.Accurate final electrode position is associated with maximum clinical benefit and improvement in dysgraphia.Reported events: sixty-four patients with a histology of parkinson's disease underwent the electrode placement for deep brain stimulation(dbs).The article specifically sites three patients with deviations more than 3mm on the left electrode had a deterioration in their gait score.One patient was not able to hold a pen in the post operative period due to extensive tremors.For the right electrodes, there were fifty-two deviations less than 3.5 mm found, and five deviations greater than 3.5mm.Eight deviations were associated with deterioration of a patient's speech scores.Another eight deviations were associated with deterioration of a patient's gait scores, and two deviations were associated with deterioration of a patient's bradykinesia scores.For the left electrodes, there were sixty deviations less than 3.5 mm found, and two deviations greater than 3.5mm.Eight deviations were associated with deterioration of a patient's speech scores.Another six deviations were associated with deterioration of a patient's gait scores, and two deviations were associated with deterioration of a patient's bradykinesia scores.

• 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: 13122401
• MDR Text Key: 286534735
• Report Number: 1723170-2021-02993
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/30/2021
• 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
• Patient Age: 57 YR
• Patient Sex: Male