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 Edema (1820); Intracranial Hemorrhage (1891); Hemorrhage, Subdural (1894); Seizures (2063)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Atchley tj, elsayed ga, sowers b, et al.Incidence and risk factors for seizures associated with deep brain stimulation surgery.J neurosurg.2020:1-5.10.3171/2020.5.Jns20125.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.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku; product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku; product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku; product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku; product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku; product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku; product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: the objective of this study was to determine the incidence of seizures following deep brain stimulation (dbs) electrode implantation and to evaluate factors associated with postoperative seizures.The authors performed a single-center retrospective case-control study.The outcome of interest was seizure associated with dbs implantation.Univariate analyses were performed using the student t-test for parametric continuous outcomes.The authors used the kruskal-wallistest or wilcoxon rank-sum test for nonparametric continuous outcomes, chi-square statistics for categorical outcomes, and multivariate logistic regression for binomial variables.A total of 814 dbs electrode implantations were performed in 645 patients (478 [58.7%] in men and 520 [63.9%] in patients with parkinson¿s disease).In total, 22 (3.4%) patients who had undergone 23 (2.8%) placements experienced seizure.Of the 23 dbs implantation¿related seizures, 21 were new-onset seizures (3.3% of 645 patients) and 2 were recurrence or worsening of a prior seizure disorder.Among the 23 cases with post implantation-related seizure, epilepsy developed in 4 (17.4%) postoperatively; the risk of dbs-associated epilepsy was 0.50% per dbs electrode placement and 0.63% per patient.Nine (39.1%) implantation-related seizures had associated postoperative radiographic abnormalities.Multivariate analyses suggested that age at surgery conferred a modest increased risk for postoperative seizures (or 1.06, 95% ci 1.02¿1.10).Sex, primary diagnosis, electrode location and sidedness, and the number of trajectories were not significantly associated with seizures after dbs surgery.Seizures associated with dbs electrode placement are uncommon, typically occur early within the postoperative period, and seldom lead to epilepsy.This study suggests that patient characteristics, such as age, may play a greater role than perioperative variables in determining seizure risk.Multi institutional studies may help better define and mitigate the risk of seizures after dbs surgery.Reported events: 12 patients implanted with deep brain stimulation (dbs) experienced postoperative seizure associated with lead implant with no radiographic abnormality.Two patients implanted with dbs experienced new-onset dbs electrode placement-associated epilepsy and focal lead edema on postoperative imaging.One patient implanted with dbs experienced new-onset dbs electrode placement-associated epilepsy and had small tract hemorrhage on postoperative imaging.The authors indicated that hemorrhages were subdural and/or intraparenchymal.One patient implanted with dbs experienced new-onset dbs electrode placement-associated epilepsy with no radiographic abnormality.Four patients implanted with dbs experienced postoperative seizure associated with lead implant and had hemorrhage on postoperative imaging.The authors indicated that hemorrhages were subdural and/or intraparenchymal.Two patients implanted with dbs experienced postoperative seizure associated with lead implant and had electrode-associated edema.One patient implanted with dbs experienced an additional case seizure associated lead implant.Of the reported events above, all but one case was confirmed to have resolved; 14 resolved within 24 hours and 8 greater than 24 hours (one was missing).Relevant medical history: parkinson's disease diagnosis (n=16), other diagnosis (n=6), pre-existing seizure disorder (n=2), subthalamic nucleus (stn) target (n=16), ventralis intermediate nucleus (vim) of the thalamus target (n=5), internal globus pallidus (gpi) target (n=2).No specific device information could be identified in the 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: 10674123
• MDR Text Key: 215334795
• Report Number: 2182207-2020-01063
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 09/16/2020
• 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