Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis.
adverse events
complications
deep brain stimulation
fda
maude
parkinson’s disease
Journal
Cureus
ISSN: 2168-8184
Titre abrégé: Cureus
Pays: United States
ID NLM: 101596737
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
accepted:
09
06
2021
entrez:
19
7
2021
pubmed:
20
7
2021
medline:
20
7
2021
Statut:
epublish
Résumé
Introduction Deep brain stimulation (DBS) is a modality of treatment for medication refractory Parkinson's disease (PD) in patients with debilitating motor symptoms. While potentially life-changing for individuals with Parkinson's disease, characterization of adverse events for these DBS devices have not yet been systematically organized. Therefore, the goal of this study was to characterize reported complications of DBS devices reported to the Food & Drug Administration over the last 10 years. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was utilized to retrieve entries reported under "Stimulator, Electrical, Implanted, For Parkinsonian Symptoms" between July 31, 2010 and August 1, 2020. After removing duplicate entries, each unique adverse event reported was sorted into complication categories based on the entries' provided narrative description. A final tabulation of complications was generated. Results The search query revealed 221 unique adverse events. The most common DBS devices were the Vercise Gevia, Vercise Cartesia and Vercise PC produced by Boston Scientific (Brian Walker, Boston Scientific, Marlborough, MA, USA). The most commonly reported complications were infection (16.2%) follow by lead migrations (8.6%). Other common causes of complications were circuit-related impedance (6.5%), cerebral bleeds (6.3%), device failure (6.3%) and device-related trauma (4.5%). Over a third (40%) of all devices reported with adverse events required returning to the operating room for explant or revision. Conclusion The most common complications of DBS systems are infections followed by lead migrations. Further research is needed to minimize infection rates associated with DBS systems and to reduce intrinsic device malfunctions for patients in the future.
Identifiants
pubmed: 34277165
doi: 10.7759/cureus.15539
pmc: PMC8269991
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e15539Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2021, Bennett et al.
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Dtsch Arztebl Int. 2016 Apr 22;113(16):271-8
pubmed: 27159141
J Neurol Neurosurg Psychiatry. 2013 Nov;84(11):1258-64
pubmed: 23781007
J Clin Neurosci. 2019 Nov;69:88-92
pubmed: 31445813
Lancet Neurol. 2010 Jun;9(6):581-91
pubmed: 20434403
Lancet Neurol. 2018 Nov;17(11):939-953
pubmed: 30287051
Neuromodulation. 2022 Feb;25(2):263-270
pubmed: 35125145
Neuromodulation. 2017 Jan;20(1):51-62
pubmed: 28042905
Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):124-31
pubmed: 25563662
N Engl J Med. 2003 Nov 13;349(20):1925-34
pubmed: 14614167
Neurology. 2020 Jul 28;95(4):e384-e392
pubmed: 32611633
PLoS One. 2017 Sep 13;12(9):e0183711
pubmed: 28902876
Arch Neurol. 2011 Feb;68(2):165
pubmed: 20937936
Stereotact Funct Neurosurg. 2016;94(1):18-23
pubmed: 26882003
Lancet Neurol. 2012 May;11(5):429-42
pubmed: 22516078
Neuron. 2006 Oct 5;52(1):197-204
pubmed: 17015236
Mov Disord. 2008 Apr 30;23(6):790-6
pubmed: 18361474
Neuromodulation. 2018 Apr;21(3):296-301
pubmed: 29345415
Parkinsonism Relat Disord. 2015 Oct;21(10):1247-50
pubmed: 26234953
Br J Neurosurg. 2021 Feb;35(1):57-64
pubmed: 32476485
Lancet Neurol. 2009 Jan;8(1):67-81
pubmed: 19081516
World Neurosurg. 2012 Mar-Apr;77(3-4):569-76
pubmed: 22120348
Brain. 2005 Oct;128(Pt 10):2240-9
pubmed: 15975946
N Engl J Med. 2001 Sep 27;345(13):956-63
pubmed: 11575287
Reg Anesth Pain Med. 2019 Jan;44(1):100-106
pubmed: 30640660
Arch Neurol. 2011 Dec;68(12):1550-6
pubmed: 21825213
N Engl J Med. 2006 Aug 31;355(9):896-908
pubmed: 16943402
J Neurochem. 2014 Aug;130(4):472-89
pubmed: 24773031
No Shinkei Geka. 2019 Oct;47(10):1037-1043
pubmed: 31666419
Brain Imaging Behav. 2020 Feb;14(1):62-71
pubmed: 30267364
JAMA. 2009 Jan 7;301(1):63-73
pubmed: 19126811
J Neurol Neurosurg Psychiatry. 2006 Jan;77(1):12-7
pubmed: 16361585
J Neurol Sci. 2017 Dec 15;383:135-141
pubmed: 29246601
J Neurosurg. 2018 Mar 1;:1-10
pubmed: 29521584
J Neurosurg. 2007 Apr;106(4):621-5
pubmed: 17432713
Mov Disord. 2014 Nov;29(13):1615-22
pubmed: 24821648