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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891); Cognitive Changes (2551)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Age.This value is the average age 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.(b)(4).

Event Description

On (b)(6) 2020 frequin hl, bot m, dilai j, et al.Relative contribution of magnetic resonance imaging, microelectrode recordings, and awake test stimulation in final lead placement during deep brain stimulation surgery of the subthalamic nucleus in parkinson's disease.Stereotact funct neurosurg.2020:1-11.10.1159/000505710.Data on seventy-six patients that underwent implantation of 146 dbs leads.Pd patients undergoing mri targeted stn dbs surgery with three-channel mer and awake test stimulation between february 2010 and january 2014 were analyzed to determine in which mer trajectory final leads were implanted and why this tract was chosen.Reported events: one patient had a symptomatic subcortical hemorrhage manifesting in delirium.The patient recovered fully.In 3 patients a postoperative ct scan showed an asymptomatic postoperative intracerebral hemorrhage.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9967994
• MDR Text Key: 196913981
• Report Number: 2182207-2020-00140
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/16/2020
• 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 Outcome(s): Other
• Patient Age: 59 YR