MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION LEAD; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	NEU_UNKNOWN_LEAD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Ischemia (1942); Nausea (1970); Paralysis (1997); Dysphasia (2195); Quadriplegia (2449); Cognitive Changes (2551)
Date of Event	07/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Cui, z.; chen, t.;wang, j.; jiang, c.; gao, q.; mao, z.; pan, l.; ling, z.; zhang, j.; li, x.The long-term efficacy, prognostic factors, safety, and hospitalization costs following denervation and myotomy of the affected muscles and deep brain stimulation in 94 patients with spasmodic torticollis.Brain sci.2022, 12, 881.Doi: doi.Org/10.3390/brainsci12070881 summary: the surgical methods for treating spasmodic torticollis include the denervation and myotomy (dam) of the affected muscles and deep brain stimulation (dbs).This study reports on the long-term efficacy, prognostic factors, safety, and hospitalization costs following these two procedures.We collected data from 94 patients with spasmodic torticollis, of whom 41 and 53 were treated with dam and dbs, respectively, from june 2008 to december 2020 at the chinese people¿s liberation army general hospital.We used the tsui scale and the global outcome score of the toronto western spasmodic torticollis rating scale (twstrs) to evaluate the preoperative and postoperative clinical conditions in all patients.We also determined the costs of hospitalization, prognostic factors, and serious adverse events following the two surgical procedures.The mean follow-up time was 68.83 months (range = 13¿116).Both resection surgery and dbs showed good results in terms of tsui (z = 5.103, p = 0.000; z = 6.210, p = 0.000) and twstrs scores (t = 8.762, p = 0.000; z = 6.308, p =0.000).Compared with the dam group, the preoperative (47.71, range 24¿67.25) and postoperative (18.57, range 0¿53) twstrs scores in the dbs group were significantly higher (z = 3.161, p = 0.002).We found no correlation between prognostic factors and patient age, gender, or disease duration for either surgical procedure.However, prognostic factors were related to the length of the postoperative follow-up period in the dbs surgery group (z = 2.068, p = 0.039; z = 3.287, p = 0.001).The mean hospitalization cost in the dbs group was 6.85 times that found in the resection group (z = 8.284, p = 0.000).The total complication rate was 4.26%.We found both resection surgery and dbs showed good results in the patients with spasmodic torticollis.Compared with dam, dbs had a greater improvement in twstrs score; however, it was more expensive.Prognostic factors were related to the length of the postoperative follow-up period in patients who underwent dbs surgery.Reported events: 1.It was reported that one patient experienced intraoperative bleeding.Specifically, a fresh blood outflow conduit formed during the dbs procedure.The operation was immediately suspended, and strict blood pressure control was applied along with hemostatic agents.An intraoperative mri revealed a large amount of hemorrhaging (about 20ml).To address this, a drainage tube was implanted via stereotactic guidance in the hematoma through another bone hole, and the patient was immediately subjected to intraoperative hematoma aspiration.With the consistent maintenance of the drainage, the patient had only mild hemiplegia, representing a good outcome.2.It was reported that one patient an intraoperative mri revealed ischemia in the left frontal lobe.Symptoms in the acute phase included headache, nausea, partial aphasia, cognitive changes, and hallucinations, although there were no long term complications.3.It was reported that one patient suffered from an infection at the neck incision after the triad procedure, which was resolved with debridement.4.It was reported that one patient suffered from moderate quadriplegia after the subdural selective c3-5 sensory nerve root rhizotomy.A ct scan showed a postoperative epidural hematoma in the surgical area.This hematoma was removed, and limb muscle strength was basically restored afterwards such that the patient had no permanent hemiplegia.
Additional Manufacturer Narrative
Concomitant products: product id: neu_unknown_lead, lot# unknown, product type: lead.Product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id: neu_unknown_lead, lot#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown, citation: cui, z.; chen, t.;wang, j.; jiang, c.; gao, q.; mao, z.; pan, l.; ling, z.; zhang, j.; li, x.The long-term efficacy, prognostic factors, safety, and hospitalization costs following denervation and myotomy of the affected muscles and deep brain stimulation in 94 patients with spasmodic torticollis.Brain sci.2022, 12, 881.Doi: doi.Org/10.3390/brainsci12070881.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 [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.

• Brand Name: LEAD
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 15375100
• Report Number: 2182207-2022-01708
• Device Sequence Number: 5565181
• Product Code: MRU
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 09/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male