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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Unspecified Infection (1930); Post Operative Wound Infection (2446); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3387, lot#: unknown, product type: lead.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: 3387, lot#: unknown, product type: lead.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: 3387, lot#: unknown, product type: lead.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.The main component of the system.Other relevant device(s) are: product id: 3387, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: 3387, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: 3387, serial/lot #: unknown.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 [or the date that the article was accepted for publication] 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.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.

Event Description

Cui, z., wang, j., mao, z., pan, l., jiang, c., gao, q., ling, z., xu, b., yu, x., zhang, j., chen, t.Long-term efficacy, prognostic factors, and safety of deep brain stimulation in patients with refractory tourette syndrome: a single center, single target, retrospective study.Journal of psychiatric research 151 (2022) 523¿530.Doi: 10.1016/j.Jpsychires.2022.05.025.Summary: background: to evaluate the long-term efficacy, prognostic factors, and safety of posteroventral globus pallidus internus deep brain stimulation (dbs) in patients with refractory tourette syndrome (rts).Methods: this retrospective study recruited 61 patients with rts who underwent posteroventral globus pallidus internus (gpi) dbs from january 2010 to december 2020 at the chinese people¿s liberation army general hospital.The yale global tic severity scale (ygtss), yale-brown obsessive-compulsive scale (ybocs), beck depression inventory (bdi), gilles de la tourette syndrome quality-of-life scale (gts-qol) were used to evaluate the preoperative and postoperative clinical condition in all patients.Prognostic factors and adverse events following surgery were analyzed.Results: patient follow up was conducted for an average of 73.33 ± 28.44 months.The final postoperative ygtss (32.39 ± 22.34 vs 76.61 ± 17.07), ybocs (11.26 ± 5.57 vs 18.31 ± 8.55), bdi (14.36 ± 8.16 vs 24.79 ± 11.03) and gts-qol (39.69 ± 18.29 vs 78.08 ± 14.52) scores at the end of the follow-up period were significantly lower than those before the surgery (p < 0.05).While age and the duration of follow-up were closely related to prognosis, the disease duration and gender were not.No serious adverse events were observed and only one patient exhibited symptomatic deterioration.Conclusions: posteroventral-gpi dbs provides long-term effectiveness, acceptable safety and can improve the quality of life in rts patients.Moreover, dbs is more successful among younger patients and with longer treatment duration.Reported events: 1.Fracturing of electrodes occurred in 4 cases.In one case the connector shifted to the neck, accompanied by the fracture of the electrode wire.2.Equipment failure was reported in one patient.They replaced it with a new one.3.Infection was reported in 3 cases.4.One patient had self injury involving hitting an object with the head or patting the head with hands.The device was removed because the electrode wire at the head is exposed.5.One patient had self injury involving hitting an object with the head or patting the head with hands.They retained the electrode after controlled local wound infection.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 14921376
• MDR Text Key: 295315686
• Report Number: 2182207-2022-01254
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2022

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: 06/06/2022
• Initial Date FDA Received: 07/05/2022
• 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 Sex: Male