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

Model Number NEU_INS_STIMULATOR

Device Problems Intermittent Continuity (1121); Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Pain (1994); Paresis (1998); Neck Stiffness (2434); Paresthesia (4421); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2023

Event Type  Injury  

Manufacturer Narrative

A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.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.D10.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.

Event Description

Blomstedt, y., stenmark persson, r., awad, a., hariz, g.-m., philipson, j., hariz, m., fytagoridis, a.And blomstedt, p.(2023), 10 years follow-up of deep brain stimulation in the caudal zona incerta/posterior subthalamic area for essential tremor.Mov disord clin pract.Https://doi.Org/10.1002/mdc3.13729 abstract: background: background long-term data on the effects of deep brain stimulation (dbs) for essential tremor (et) is scarce, especially regarding dbs in the caudal zona incerta (czi) and the posterior subthalamic area (psa).Objectives: objectives the aim of this prospective study was to evaluate the effect of czi/psa dbs in et at 10 years after surgery.Methods: methods thirty-four patients were included.All patients received czi/psa dbs (5 bilateral/29 unilateral) and were evaluated at regular intervals using the essential tremor rating scale (etrs).Results: results one year after surgery, there was a 66.4% improvement of total etrs and 70.7% improvement of tremor (items 1¿9) compared with the preoperative baseline.Ten years after surgery, 14 patients had died and 3 were lost to follow-up.In the remaining 17 patients, a significant improvement was maintained (50.8% for total etrs and 55.8% for tremor items).On the treated side the scores of hand function (items 11¿14) had improved by 82.6% at 1 year after surgery, and by 66.1% after 10 years.Since off-stimulation scores did not differ between year 1 and 10, this 20% deterioration of on-dbs scores was interpreted as a habituation.There was no significant increase in stimulation parameters beyond the first year.Conclusions: conclusions this 10 year follow up study, found czi/psa dbs for et to be a safe procedure with a mostly retained effect on tremor, compared to 1 year after surgery, and in the absence of increase in stimulation parameters.The modest deterioration of effect of dbs on tremor was interpreted as habituation.Reported events: 1.A 72 year old woman suffered a suspected stroke shortly after surgery with the development of hemiparesis.This was deemed to be a consequence of surgery.The symptoms were mostly in regression after 5 months, with a remaining weakness of the leg.2. two patients underwent revisions due to straining extension cables.3. one patient had a malfunction of the implantable neurostimulator (ins) that affected some contacts, but had no relevance for the clinical outcome.4. one patient had a suspected poor connection between the implantable neurostimulator (ins) and connection cable with intermittent sensations of electrical leakage was resolved by external manipulation of the device.5. one patient's electrode was misplaced too medially close to the red nucleus, and a suboptimal effect with 75% tremor reduction had to be accepted to avoid stimulation induced side effects.A good effect was achieved after several years when the depleted implantable neurostimulator (ins) was replaced with a newer model, providing more advanced programming options.6. one patient complained over painful paresthesia in the tongue for some seconds, each morning when she started the stimulation.This was resolved when the implantable neurostimulator (ins) was changed to a new model upon depletion, providing more advanced programming options.7.There were 26 complications deemed as minor recorded.The following device specifics were provided: lead model 3389 and 3387, ins model 7428 kinetra and 37601 activa pc.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16882719
• MDR Text Key: 314711401
• Report Number: 2182207-2023-00816
• Device Sequence Number: 1
• Product Code: PJS
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• 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: 05/12/2023
• 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: 65 YR
• Patient Sex: Female