MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

Device Problem Malposition of Device (2616)

Patient Problems Seizures (2063); Seroma (2069); Cognitive Changes (2551)

Event Type  Injury  

Event Description

Chiou, s.M., lin, y.C., lu, m.K., tsai, c.H.Bilateral subthalamic stimulation for advanced parkinson disease: early experience at an eastern center.Neurological sciences : official journal of the italian neurological society and of the italian society of clinical neurophysiology.2014.Doi 10.1007/s10072-014-2008-x summary: deep brain stimulation (dbs) of the subthalamic nucleus (stn) can improve the life quality of patients with advanced parkinson disease (pd).However, previous studies have stemmed mainly from (b)(6).Present study analyzed the 6-month outcomes of bilateral stn-dbs therapy that were observed during a 9-year period at a (b)(6).We retrospectively reviewed 72 consecutive patients, whose mean disease history was 8 years when they underwent surgery.The median ¿¿drug-off¿¿ hoehn and yahr stage was 3.The stn was targeted using t2-weighted magnetic resonance imaging and electrophysiological guidance.The over-time mean differences in the unified pd rating scale (updrs) scores and daily levodopa-equivalent dose (led) were assessed using the repeated measurements anova at 3 and 6 months relative to those of presurgical drug-off baseline.At 6 months postsurgery, the mean updrs total, part ii and part iii subscores significantly decreased by 27, 30 and 25 %, respectively, with clinically high effect size.Tremors were markedly (66 %) ameliorated.Moreover, problems of akinesia, rigidity, and locomotion were significantly improved by 20 %.The mean daily led needs decreased by 25 %; thus, drug-induced dyskinesia was markedly (80 %) diminished.Stn-dbs therapy could provide similarly effective impacts to eastern and western pd patients.Preoperative optimal selection of patients and postoperative delicate programming ensure a better surgical improvement.Reported events: two patient with deep brain stimulation (dbs) for parkinson¿s disease experienced a seizure the day after implantation.It was noted that the patient subsequently exhibited a smooth treatment course.Two patients with dbs for parkinson¿s disease had malpositioned right leads, which were relocated when the implantable neurostimulator (ins) was implanted.It was noted that the patients subsequently exhibited a smooth treatment course.Two patients with deep brain stimulation (dbs) for parkinson¿s disease experienced acute psychosis for 3-4 days.It was noted that the patients subsequently exhibited a smooth treatment course.One diabetic patient with dbs for parkinson¿s disease experienced fluid accumulation in the chest ins pocket within one week; therefore, the ins was removed immediately and re-implanted four months later.It was noted that the patient subsequently exhibited a smooth treatment course.The source literature included the following device specifics: lead model 3389 and kinetra ins model 7428 further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

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.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.Concomitant: product id 3389, lot# unknown, product type lead.Product id 7428, product type implantable neurostimulator.Product id 7428, product type implantable neurostimulator.Product id 7428, product type implantable neurostimulator.Product id 3389, product type lead.Product id 7428, product type implantable neurostimulator.(b)(4).

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4376136
• MDR Text Key: 5258910
• Report Number: 3007566237-2014-03847
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Physician
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• 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
• Date Manufacturer Received: 12/04/2014
• 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; Required Intervention
• Patient Age: 00061 YR