MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number NEU_INS_STIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dementia (1808); Unspecified Infection (1930); Memory Loss/Impairment (1958); Muscular Rigidity (1968); Dysphasia (2195); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Cognitive Changes (2551)
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Event Date 01/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: 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 as the event dates were not provided in the published literature.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown.Gruber, d., calmbach, l., kuhn, aa, krause, p., kopp, ua., schneider, gh., kupsch, a."longterm outcome of cognition, affective state, and quality of life following subthalamic deep brain stimulation in parkinson's disease." j neural transm (vienna).2019.Doi: 10.1 007/s00702-019-01972-7.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Summary: normal cognition is an established selection criteria for subthalamic (stn) deep brain stimulation (dbs) in parkinson¿s disease (pd), while concern has been raised as to aggravated cognitive decline in pd patients following stn-dbs.The present longterm study investigates cognitive status in all patients (n = 104) suffering from pd, who were treated via continuous bilateral stn-dbs between 1997 and 2006 in a single institution.Preoperative neuropsychological results were available in 79/104 of the patients.Thirty-seven of these patients were additionally assessed after 6.3 ± 2.2 years (range 3.6¿10.5 years) postsurgery via neuropsychological and motor test batteries, classifying cognitive conditions according to established criteria.At dbs-surgery patients, available for longterm follow-up (n = 37; mean age 67.6 ± 6.9 years, mean disease duration 11.3 ± 4.1 years), showed no (24.3%; 9/37) or mild preoperative cognitive impairment (mci, 75.7%; 28/37).Postoperatively (mean disease duration: 17.1 ± 5.1 years), 19% of the patients (7/37) had no cognitive impairment, while 41% of the patients presented with either mci or dementia (15/37, respectively).Preoperative mci correlated with conversion to dementia by trend.Overall, stn-dbs-treated patients deteriorated by 1.6/140 points/year in the mattis dementia rating scale.Disease duration, but not age, at dbs-surgery negatively correlated with postoperative cognitive decline and positively correlated with conversion to dementia.This observational, ¿real-life¿ study provides longterm results of cognitive decline in stndbs- treated patients with presurgical mci possibly predicting the conversion to dementia.Although, the present data is lacking a control group of medically treated pd patients, comparison with other studies on cognition and pd do not support a disease-modifying effect of stn-dbs on cognitive domains.Reported events: 15 patients with stn-dbs for pd developed dementia according to level 1-criteria as of 6 years post implant.13 of these patients had preoperative mild cognitive impairment.Parkinson¿s disease dementia (pd-d) patients worsened significantly compared to pd-mc/nc patients with respect to global cognition (mmdrs, p 0.001), comprising the domains memory (ravlt, immediate and delayed recall), executive function (tmt b), language (semantic and phonematic fluency), and attention (tmt a).Additionally, pd-d patients showed more pronounced deterioration of updrs motor subscores (bradykinesia, p = 0.012; rigidity, p = 0.018; axial symptoms¿summary score of speech, posture, gait and postural stability, p = 0.032).The authors suggested that development of dementia post-implant was correlated with disease duration.3 patients with stn-dbs for pd had the system explanted due to infection.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.
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