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

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Death (1802); Intracranial Hemorrhage (1891); Cognitive Changes (2551)

Event Date 02/13/2020

Event Type  Death  

Manufacturer Narrative

Krause p, volzmann s, ewert s, kupsch a, schneider gh, kuhn aa.Long-term effects of bilateral pallidal deep brain stimulation in dystonia: a follow-up between 8 and 16 years.J neurol.2020.10.1007/s00415-020-09745-z.Patient age: 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.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.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.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: observational study to evaluate the long-term motor and non-motor effects of deep brain stimulation (dbs) of the globus pallidus internus (gpi) on medically refractory dystonia.Dystonia is a chronic disease affecting mainly young patients with a regular life expectancy and lifelong need for therapy.Pallidal dbs is an established/ treatment for severe isolated dystonia /ut long-term data are sparse.The authors considered 36 consecutive patients with isolated generalized (n = 14) and cervical/segmental (n = 22) dystonia operated at (b)(6)-university hospital between 2000 and 2007 in a retrospective analysis for long-term outcome of pallidal dbs.In 19 of these patients, we could analyze dystonic symptoms and disability rated by the burke¿fahn¿marsden dystonia rating scale (bfmdrs) at baseline, short-term (st-fu, range 3¿36 months) and long-term follow-up (lt-fu, range 93¿197 months).Quality of life and mood were evaluated using the sf36 and beck depression index (bdi) questionnaires.Patients reached an improvement in motor symptoms of 63.8 ± 5.7% (mean ± se) at st-fu and 67.9 ± 6.1% at lt-fu.Moreover, a significant and stable reduction in disability was shown following dbs (54.2 ± 9.4% at st-fu and 53.8 ± 9.2% at lt-fu).Bdi and sf36 had improved by 40% and 23%, respectively, at lt-fu (n = 14).Stimulation-induced adverse events included swallowing difficulties, dysarthria, and bradykinesia.Pulse generator (n = 3) and electrodes (n = 5) were revised in seven patients due to infection.Pallidal dbs is a safe and efficacious long-term treatment for dystonia with reported events: 1.One patient implanted with bilateral internal globus pallidus (gpi) deep brain stimulation (dbs) for dystonia committed suicide 2 years after bilateral pallidal stimulation.2.One patient implanted with bilateral gpi-dbs for dystonia died in consequence of intracerebral bleeding following lysis therapy due to post-operative systemic pulmonary embolism two days after bilateral pallidal lead re-implantation.The following device information was identified in the literature article: ins models 37612, 37601, 7428 and lead models 3387 and 3389.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9848321
• MDR Text Key: 183965362
• Report Number: 2182207-2020-00029
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• 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
• Date Manufacturer Received: 03/03/2020
• 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): Death
• Patient Age: 50 YR