MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Wang t, zhang cc, li dy, sun bm, fu m.Imaging law of postoperative electrode locations in deep brain stimulation for parkinson's disease.Journal of shanghai jiaotong university (medical science).2020;40(1):64-69.10.3969/j.Issn.1674-8115.2020.01.010.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Information references the main component of the system.Other relevant device(s) are: product id: 3387, serial/lot #: unknown, ubd: , udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: forty-nine pd patients who underwent dbs treatment in department of functional neurosurgery of ruijin hospital, shanghai jiao tong u niversity school of medicine from jan.2016 to dec.2017 were selected.Ct images were acquired 3¿5 days after surgery and mri images were acquired during 3¿6 months by the follow-up of regular programming.The fused images of short-term ct combined with preoperat ive mri and long-term mri respectively were compared to show the difference by the tip contact positions of electrodes.A total of 50 groups of postoperative ct fused images and mri images were obtained.The space differences of the two types of images were 1.36 (0.98, 1.70) mm (p=0.021) and 1.28 (0.99, 1.88) mm (p=0.006), on the right and left electrodes, respectively.Bilateral electrodes in both short-term and long-term images had a tendency to move to the medial, rear, and bottom part of the brain.The potential tendency in shifts of dbs electrodes can provide reference for establishing the brain drift model and optimizing the position of the implanted electrode.Reported events: an unknown number of patients experienced definite relative displacement of the bilateral leads in the long term.Deep brain stimulation (dbs) leads exhibited difference in 3 directions as well as spatial distance.Pneumocephalus, mostly distributed near the forehead and the drill hole, which had a significant impact on the change of electrode position after surgery.The following device specifics were identified in the literature article:  lead model 3387 see attached literature article.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11742352
• MDR Text Key: 262881340
• Report Number: 2182207-2021-00719
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2021
• 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 Age: 63 YR