MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event.Please note that this date is based off the date that the article was accepted for publication as the event dates were not provided in the published literature.The main component of the system involved in the reported event; other applicable components are: product id: neu_unknown_lead, lot# unknown, product type: lead.Kloc, m., kosutzka, z., steno, j., valkovic, p.Prevalent placement error of deep brain stimulation electrode in movement disorders (technical considerations).Bratisl lek listy.2017;118(11):647-653.Doi: 10.4149/bll_2017_123.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: background: deep brain stimulation is an effective and safe technique.Displacement of the electrode relative to the optimal stimulation site can lead to insufficient effect and sometimes to the need of operative electrode re-position.Objective: this study was aimed to analyse targeting accuracy of deep brain stimulation electrode implantation to subthalamic nucleus (stn) and globus pallidus internus (gpi).It detected possible causes of inaccuracy and prevalent shift to certain direction.Methods: targeting accuracy was analysed in 47 patients with parkinson´s disease (pd) and 11 patients with dystonia with bilateral implantation of deep brain stimulation electrodes between years 2009 and 2016.Results: a shift of electrode to prevalent direction was observed on the left side to medial and posterior and on the right side to lateral direction.Greater shift was observed on the left side and in a higher angulation of trajectory laterally.Movement of the electrode, because of its traction in anchoring device, was identified as a possible factor for prevalent electrode shift.Calibration of stereotactic coordinates to correct prevalent shift was used.Conclusion: targeting inaccuracy is the result of accumulation of errors in individual steps of electrode implantation.Direction of the shift can be random or it can be toward a prevalent direction.A correction of prevalent error can prevent a suboptimal electrode placement.1.An unclear number of patients with globus pallidus internus (gpi)-deep brain stimulation (dbs) for dystonia experienced a shift of the right electrode lateral to the planned trajectory and bending of the electrode with ¿medial convexity.¿ the authors reported an average vector error in the x-axis of 0.8 mm and 0.06 mm in the y-direction.On the left side of the brain the noted vector errors were 0.5 mm in the x-axis and 0.41 mm in the y-axis.Notably, the authors only described errors of greater than 2 mm as ¿potentially important.¿ it was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 7318440
• MDR Text Key: 102080172
• Report Number: 3007566237-2018-00664
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• 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