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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Vazquez-barron d, cuellar-herrera m, velasco f, velasco al.Electrical stimulation of subiculum for the treatment of refractory mesial temporal lobe epilepsy with hippocampal sclerosis: a 2-year follow-up study.Stereotactic and functional neurosurgery.2020:1-8.10.1159/000510295.Age/sex: see for patient demographic details.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.Information references the main component of the system.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown, ubd: asku, implanted: unknown, explanted: unknown, udi#: asku.Product id: 3387, serial/lot #: unknown, ubd: asku, implanted: unknown, explanted: unknown, udi#: asku ; (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: evidence has been provided that the subiculum may play an important role in the generation of seizures.Electrical stimulation at this target has been reported to have anticonvulsive effects in kindling and pilocarpine rat models, while in a clinical study of hippocampal deep brain stimulation (dbs), contacts closest to the subiculum were associated with a better anticonvulsive effect.Six patients with refractory mtle and hs, who had focal impaired awareness seizures (fias) and focal to bilateral tonic-clonic seizures (fbtcs), had dbs electrodes implanted in the subiculum.During the first month after implantation, all patients were off stimulation, then they all completed an open-label follow-up of 24 months on stimulation.Dbs parameters were setat 3 v, 450 s, 130 hz, cycling stimulation 1 min on, 4 min off.There was a mean reduction of 49.16% (±sd 41.65) in total seizure number (fias + fbtcs) and a mean reduction of 67.93% (±sd 33.33) in fbtcs at 24 months.Fbtcs decreased significantly with respect to baseline, starting from month 2 on stimulation.Subiculum stimulation is effective for fbtcs reduction in patients with mtle and hs, suggesting that the subiculum mediates the generalization rather than the genesis of mesial temporal lobe seizures.Better results were observed at longer follow-up times.Reported events: a (b)(6) year old male patient implanted for epilepsy experienced increased total seizures (20%) at 24 month follow-up, but had 50% reduction of focal to bilateral tonic-clonic seizures (fbtcs).The patient had focal impaired awareness seizures (fias) and fbtcs at baseline.Total seizure increase was observed only during 3 non-continuous months, and he was fbtcs free for 17 months.The remain ing seizures were exclusively nocturnal.A (b)(6) year old male patient implanted for epilepsy experienced increased total seizure count during most of follow-up, which was related to fias increase.Fbtcs were decreased during all of the study, and was 100% reduced by the end of the study.A (b)(6) year old male patient implanted for epilepsy experienced a lead fracture during a seizure in the first month after implant.The patient was re-implanted successfully and continued the study.The following device information was identified in the article: activa sc ins (it could not be determined if model 37602 and/or 37603 was/were used), lead model 3387.

• 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: 11113793
• MDR Text Key: 228426750
• Report Number: 2182207-2021-00008
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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: 12/10/2020
• 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): Required Intervention