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 Problem Unspecified Infection (1930)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 3389, serial/lot #: unknown.Age: this value is the average age of the patients reported in the article as specific patients could not be identified.Gender: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Event date: 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Chen w, yu x, wang n, jing j, ma x, li r.The therapeutic effect of deep brain stimulation at medial globus pallidus and subthalamic nucleus on treating parkinson disease.Acta medica mediterranea.2021;37(5):2293-2300.10.19193/0393-6384_2021_5_356.The objective was to explore the improvements and therapeutic effects of deep brain stimulation on the symptoms and living quality of patients with parkinson disease.A total of 82 patients with parkinson disease who underwent deep brain stimulation in the neurosurgery department at the first affiliated hospital of xi¿an jiaotong university from may 2016 to january 2019 were enrolled.The clinical symptoms, disease severity, disability, and quality of life of enrolled patients were evaluated at 1 week before the surgery and 6 months after the surgery.Reported events: 3 cases of device stimulated skin infections occurred.4 cases of post-operative intracranial infection occurred.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.See attached literature article.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 3389, serial/lot #: unknown.Age: this value is the average age of the patients reported in the article as specific patients could not be identified.Gender: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Event date: 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Chen w, yu x, wang n, jing j, ma x, li r.The therapeutic effect of deep brain stimulation at medial globus pallidus and subthalamic nucleus on treating parkinson disease.Acta medica mediterranea.2021;37(5):2293-2300.10.19193/0393-6384_2021_5_356.The objective was to explore the improvements and therapeutic effects of deep brain stimulation on the symptoms and living quality of patients with parkinson disease.A total of 82 patients with parkinson disease who underwent deep brain stimulation in the neurosurgery department at the first affiliated hospital of xi¿an jiaotong university from may 2016 to january 2019 were enrolled.The clinical symptoms, disease severity, disability, and quality of life of enrolled patients were evaluated at 1 week before the surgery and 6 months after the surgery.Reported events: 3 cases of device stimulated skin infections occurred.4 cases of post-operative intracranial infection occurred.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.See attached literature article.

• 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: 13059633
• MDR Text Key: 285536319
• Report Number: 2182207-2021-02218
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: 11/23/2021
• 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: 62 YR
• Patient Sex: Male