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

Model Number NEU_INS_STIMULATOR

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hematoma (1884); Unspecified Infection (1930); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389, lot#: unknown, product type: lead.Other relevant device(s) are: product id: 3389, serial/lot #: unknown, udi#: (b)(4).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.If information is provided in the future, a supplemental report will be issued.

Event Description

Devaluez m, tir m, krystkowiak p, aubignat m, lefranc m.Selection of deep brain stimulation contacts using volume of tissue activated software following subthalamic nucleus stimulation.Journal of neurosurgery.2020:1-8.10.3171/2020.6.Jns192157.Brain images of 26 patients undergoing stn dbs were analyzed using vta software.Preoperative clinical and neuropsychological data were collected.Contacts were chosen by two experts in dbs blinded to the clinical data.A therapeutic window of amplitude was determined.These results were compared with the parameter settings for each patient.Data were obtained at 3 months and 1 year postsurgery.Reported events: 4 patients has postoperative complications listed as pneumocephalus, pneumopathy on inhalation, and infected pacemaker and pectoral hematoma.It was reported that in one of the patient's experienced a suboptimal lead placement, lateral to the target.It was stated this patient experienced gait abnormalities on monopolar settings so bipolar settings were used in place.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: 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: 11150776
• MDR Text Key: 231799054
• Report Number: 2182207-2021-00045
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2021

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?: 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
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/11/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR