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

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891)

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389 ,lot#: unknown, product type: lead.Other relevant device(s) are: product id: 3389, serial/lot #: unknown.Fan s, liu d, shi l, meng f, fang h, liu h, zhang h, yang a, zhang j, differential effects of subthalamic nucleus and globus pallidus internus deep brain stimulation on motor subtypes in parkinson¿s disease, world neurosurgery (2022), doi: https://doi.Org/10.1016/j.Wneu.2022.04.084.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.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.Event: 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Fan s, liu d, shi l, meng f, fang h, liu h, zhang h, yang a, zhang j, differential effects of subthalamic nucleus and globus pallidus internus deep brain stimulation on motor subtypes in parkinson¿s disease, world neurosurgery (2022), doi: https://doi.Org/10.1016/j.Wneu.2022.04.084.Summary: objective: to investigate differences in motor symptom change outcomes following bilateral subthalamic nucleus (stn) and globus pallidus internus (gpi) deep brain stimulation (dbs) in well-defined motor subtypes of parkinson¿s disease (pd) to improve clinical decision making.Methods: we included 114 patients undergoing stn-dbs and 65 patients undergoing gpi-dbs.The patients were classified as akinetic-rigid type (art), tremor-dominant type (td), and mixed type (mt) based on the preoperative the movement disorder society unified parkinson¿s disease rating scale part-¿ (mds-updrs-iii) scores in the medication-off state.Outcome measures included the med-off mds-updrs-iii and its subscores changes at the last follow-up after surgery.Outcomes were compared among different motor subtypes and between stn-dbs and gpi-dbs.Results: at the last follow-up (14.92 ± 8.35 months), td patients had greater median overall motor improvement in med-off mds-updrs-iii scores compared with art patients (62.90% vs 46.67%, p <(><<)> 0.001), regardless of stimulation target.Art patients showed greater improvement after stn-dbs compared with gpi-dbs (54.44% vs 37.21%, p <(><<)> 0.001), with improvement in rigidity, akinesia, and posture and gait disorders accounting for this difference.Conclusions: our results suggest that the different pd motor subtypes show differential responses to stn-dbs and gpi-dbs, that td patients have greater improvement than art patients, and stn-dbs has a better effect in art patients than gpi-dbs.Besides, different motor symptoms among di fferent motor subtypes may respond differently to stn-dbs vs gpi-dbs.All above may reflect the heterogeneity of pd.Longer-term outcomes across different motor subtypes and stimulation targets should be further studied.Reported events: one patient had a small amount of intracranial hemorrhage after stn-dbs, and the hematoma gradually disappeared after conservative treatment.

• 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: 14650765
• MDR Text Key: 294864901
• Report Number: 2182207-2022-01043
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/12/2022
• 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): Other
• Patient Age: 62 YR
• Patient Sex: Male