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 Hematoma (1884); Hemorrhage, Intraventricular (1892); Hemorrhage, Subdural (1894); Complaint, Ill-Defined (2331)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Ray, k., krel, m., bernstein, j., kashyap, s., ananda, a.Safety of the transventricular approach to deep brain stimulation: a retrospective review.Surgical neurology international.2019; 10 (192).Doi: 10.25259/sni_244_2019.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.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.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.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, implant date: unknown, udi#: (b)(4) ; product id: neu_unknown_lead, serial/lot #: unknown, implant date: unknown, udi#: (b)(4) ; product id: neu_unknown_lead, serial/lot #: unknown, implant date: unknown, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: anatomically, deep brain stimulation (dbs) targets such as the ventral intermediate and subthalamic nucleus are positioned such that the long axis of the nucleus is often most accessible through a transventricular trajectory.The authors hypothesized that using this trajectory does not place patients at increased risk of neurologic complications.A series of 206 patients at a single institution between 2000 and 2017 were reviewed.All patients had a confirmed transventricular trajectory and their clinical course was reviewed to assess neurologic complication rates in the postoperative period.The average length of hospital stay was 2.4 days.The most common neurologic complication was altered mental status in 1.2% of cases (four patients).This was followed by seizure in 0.6% of cases (two patients).No patients had ischemic stroke or postoperative hemiparesis.There were two mortalities in this series, one with lobar hemorrhage contralateral from the surgical site and one with a thalamic hemorrhage.There was only one confirmed intraventricular hemorrhage postoperatively; however, this was clinically asymptomatic.Although the total incidence of intraventricular or intracerebral hemorrhage cannot be reliably assessed from this data set, the low incidence of neurologic complications challenges the notion that dbs electrode trajectories that transgress the ventricle significantly increase the risk of complications.Reported events: one patient implanted with dbs experienced intraventricular hemorrhage, but this was clinically asymptomatic.Postoperative imaging was performed, but the imaging was obtained based on clinical judgement.The patient was discharged home in stable condition.One patient implanted with deep brain stimulation (dbs) experienced subdural hematoma requiring emergent craniotomy.Postoperative imaging was performed, but the imaging was obtained based on clinical judgement.The authors noted that the hemorrhage was not directly associated to the electrodes passing through the ventricle.The patient was eventually transferred to a rehab facility.It was reported that some patients, "in rare cases," were deemed too unstable to be anesthetized and prepped for implantation of the ins following lead implant.Patients in the study were implanted for parkinson's disease, essential tremor, dystonia, and tourette's.In the case of the two hemorrhages (events 1 and 2), the patients were implanted with either parkinson's disease or essential tremor, but specific indication for use (ifu) for each patient could not be determined from the article.No specific device information could be identified in the published literature article.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 9446707
• MDR Text Key: 170704109
• Report Number: 3007566237-2019-02513
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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
• Date Manufacturer Received: 11/14/2019
• 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; Required Intervention
• Patient Age: 64 YR