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

Model Number UNK_NAV_SYS

Device Problem Imprecision (1307)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

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.Abstract 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: it was reported that 7 patients had deviations of more than 3mm of the electrodes.It was reported that there were at least 2 patients with more than 4 mm of deviation in their electrode.It was reported that there were 15 patients with more than 2mm of deviation in their electrode.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

• 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: 13113120
• MDR Text Key: 290073920
• Report Number: 1723170-2021-02984
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• 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
• Date Manufacturer Received: 12/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male