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

Model Number NEU_INS_STIMULATOR

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Intracranial Hemorrhage (1891); Cognitive Changes (2551); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/02/2022

Event Type  Death  

Manufacturer Narrative

Continuation of concomitant medical products: 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 neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.The main component of the system.Other relevant device(s) are: 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: neu_ins_stimulator, serial/lot #: unknown.Age or date of birth.This value is the average age of the patients reported in the article as specific patients could not be identified.Sex.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Outcomes to adverse event.Please note that the actual date of death was not provided in the literature article; this date is based on the date of article publication.Date of event.Please note that this date is based off the date that the article was accepted for publication as the event dates were not provided in the published literature.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

Hye ran park, hyung-jun im, jeongbin park, byung woo yoon, yong hoon lim, eun jin song, kyung ran kim, jae meen lee, kawngwoo park, kwang hyon park, hyun joo park, jung-hwan shin, kyung ah woo, jee young lee, suyeon park, han-joon kim, beomseok jeon, sun ha paek.Long-term outcomes of bilateral subthalamic nucleus deep brain stimulation for patients with parkinson¿s disease: 10 years and beyond.Research human clinical studies journal.Doi: 10.1227/neu.0000000000002117.Background: deep brain stimulation (dbs) of the subthalamic nucleus (stn) represents an effective treatment for severe parkinson¿s disease (pd), but little is known about the long-term benefit.Objective: to investigate the survival rate and long-term outcome of dbs.Methods: we investigated all 81 patients including 37 males and 44 females who underwent bilateral stn dbs from march 2005 to march 2008 at a single institution.The current survival status of the patients was investigated.Preoperative and postoperative follow-up assessments were analyzed.Results: the mean age at the time of surgery was 62 (range 27-82) years, and the median clinical follow-up duration was 145 months.Thirty-five patients (43%) died during the follow-up period.The mean duration from dbs surgery to death was 110.46 ± 40.8 (range 0-155) months.The cumulative survival rate is as follows: 98.8 ± 1.2% (1 year), 95.1 ± 2.4% (5 years), and 79.0 ± 4.5% (10 years).Of the 81 patients, 33 (40%) were ambulatory up to more than 11 years.The unified parkinson¿s disease rating scale (updrs) score was significantly improved until 5 years after surgery although it showed a tendency to increase again after 10 years.The patient group with both electrodes located within the stn showed a higher rate of survival and maintained ambulation.Conclusion: stn dbs is a safe and effective treatment for patients with advanced pd.This study based on the long-term follow-up of large patient populations can be used to elucidate the long-term fate of patients who underwent bilateral stn dbs for pd.Reported events: 1.It was reported that a patient who underwent bilateral stn dbs implantation committed suicide less than a month after dbs surgery.2.It was reported that 12 patients who underwent bilateral stn dbs implantation required revision surgery to reposition their electrodes.It was stated that 3 of those patients had a "failed revision surgery" and no more follow up was conducted.3.It was reported that one patient who underwent bilateral stn dbs implantation experienced hemorrhage along their lead track.4.It was reported that one patient who underwent bilateral stn dbs implantation had ins pocket abscess.10.It was reported that a patient who underwent bilateral stn dbs implantation died due to drowning.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• 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: 15820326
• MDR Text Key: 303888441
• Report Number: 2182207-2022-02157
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: 10/18/2022
• 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): Death; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female