MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION KINETRA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 7428

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Neurological Deficit/Dysfunction (1982); Post Operative Wound Infection (2446)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

This value is the average age 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 as the event dates were not provided in the published literature.Other applicable components are: product id: 3387, lot# unknown, product type: lead.

Event Description

Zhan, s., sun, f., pan, y., liu, w., huang, p., cao, c., zhang, j., li, d., sun, b.Bilateral deep brain stimulation of the subthalamic nucleus in primary meige syndrome.J neurosurg.2017:1-6.Doi: 10.3171/2016.12.Jns16383.Summary: objective subthalamic nucleus deep brain stimulation has been shown to be effective in reducing symptoms of primary meige syndrome.However, assessments of its efficacy and safety have been limited to several case reports and small studies.Methods the authors performed a retrospective study to assess the efficacy and safety of bilateral subthalamic nucleus stimulation in 15 patients with primary meige syndrome who responded poorly to medical treatments or botulinum toxin injections.Using the movement and disability subscores of the burke-fahn-marsden dystonia rating scale, the authors evaluated the severity of patients¿ dystonia and related before surgery and at final follow-up during neurostimulation.The movement scale was assessed based on preoperative and postoperative video documentation by an independent rater who was unaware of each patient¿s neurostimulation status.Quality of life was assessed with the medical outcomes study 36-item short-form general health survey.Results the dystonia movement subscores in 14 consecutive patients improved from 19.3 ± 7.6 (mean ± standard deviation) before surgery to 5.5 ± 4.5 at final follow-up (28.5 ± 16.5 months), with a mean improvement of 74% (p <(><<)> 0.05).The disability subscore improved from 15.6 ± 4.9 before surgery to 6.1 ± 3.5 at final follow-up (p <(><<)> 0.05).In addition, the postoperative sf-36 scores increased markedly over those at baseline.The authors also found that bilateral stimulation of the subthalamic nucleus immediately improved patient symptoms after stimulation and required lower stimulation parameters than those needed for pallidal deep brain stimulation for primary meige syndrome.Four adverse events occurred in 3 patients; all of these events resolved without permanent sequelae.Conclusions these findings provide further evidence to support the long-term efficacy and safety of subthalamic nucleus stimulation as an alternative treatment for patients with medically intractable meige syndrome.Reported events: a female patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for dystonia (meige syndrome) experienced a recurrent scalp wound infection despite conservative management and several attempts at wound debridement.The patient also reported worsening of dystonia 4 months after surgery that was not resolved by reprogramming.Mri revealed electrode migration on the left side, so the patient underwent removal of the electrode and pallidotomy.It was noted that all adverse events resolved without permanent sequelae.It was not possible to ascertain specific device information (i.E.Serial numbers) from the article or to match the reported event with any previously reported event.

• Brand Name: KINETRA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6699001
• MDR Text Key: 79578013
• Report Number: 3007566237-2017-02751
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/10/2017
• 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: 53 YR