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

Model Number 37601

Device Problems Break (1069); High impedance (1291); Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3389, serial#: unknown, product type: lead.Other relevant device(s) are: product id: 3389, serial/lot #: unknown, ubd: , udi#: date of event.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

Haider alaa mohammed ali, siham sabah abdullah, moneer k.Faraj.High impedance analysis in recordings of deep brain stimulation surgery.Doi.Org/10.1016/j.Inat.2021.101115.Background: deep brain stimulation (dbs) is used widely today to control many chronic neurological disorders including parkinson¿s disease (pd).During surgical procedures, an electric lead wire is inserted to stimulate a specific target of the brain.In practice, such a procedure may result in some complications that limit the clinical benefits of the treatment.Many patients have an elevation of electric impedance for the dbs lead wire which, in turn, has a restraining effect on the delivery of electrical charges with stimulation and therapy outcome coveted.Aim of the study: to analyses the complications that have been involved in dbs surgery of high impedance that affects the therapy outcome covered.Methods: the electric impedances that are inserted into five patients with dbs surgery are followed, prospectively.The impedance of the dbs electrodes is measured for an average of 9 months by utilizing the n¿ vision programmer device (medtronic, inc).Results: the impedance of the electrodes is increased and fluctuated with time.A significant high electrode impedance was noticed.It is caused by the presence of gas bubbles within the dbs electrodes site.The impedance may be changed according to the patient¿s spatial position.This high impedance affects the clinical outcome of the patient¿s condition.Conclusion: while, the impedance measurement has an essential role in follow-up time to get the best therapy results, the surgical technique of the dbs, itself, needs improvement in reducing the impedance issues.Reported events: 6.It was reported that a patient had a surgical revision due to the site of having inflammation and the ins was changed.The impedances were measured before and after surgery.The data showed a system malfunction for the right side wire of their significant short circuit after surgery was done.The recorded data was 35 ohms between electrodes 8 with all of 9, 10 and 11 respectively and 4 ohms between contacts 9 and 10, 9 and 11, 10 and 11, respectively which was due to the overstress and tension during surgery operation causing damage in the dbs wire.

• Brand Name: ACTIVA
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11887079
• MDR Text Key: 262663561
• Report Number: 2182207-2021-00904
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IZ
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• 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