Adverse events of subcutaneous loop recorders: Insights from the MAUDE database.
Internal cardiac monitor
LINQ
arrythmia
loop recorder
under-sensing
Journal
Pacing and clinical electrophysiology : PACE
ISSN: 1540-8159
Titre abrégé: Pacing Clin Electrophysiol
Pays: United States
ID NLM: 7803944
Informations de publication
Date de publication:
11 2022
11 2022
Historique:
revised:
23
03
2022
received:
09
02
2022
accepted:
15
04
2022
pubmed:
18
5
2022
medline:
16
11
2022
entrez:
17
5
2022
Statut:
ppublish
Résumé
Complications using internal cardiac monitors (ICM) have been reported at a low rate. Targeted analyses of complications have not been well described in the literature. To investigate and describe complications associated with ICM events reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Our team reviewed all reported events for the Reveal LINQ loop recorder submitted to the MAUDE database over 7 years (1/1/2013-12/31/2019). A 5% random selection of reports was audited by two researchers to ensure report validity. Two cardiologists manually reviewed death and incongruent events for final interpretation. 12,652 records were obtained during the observed time period. A total of 15,587 device complications were reported. Of this, undersensing (n = 4509, 28.93%), premature discharge of battery (n = 3262, 20.93%), oversensing (n = 2788, 17.89%), and other sensing issues (n = 1532, 9.83%) were most commonly reported. Patient adverse events were reported 1,030 times. Pain or discomfort (n = 275, 26.70%), site infection (n = 213, 20.68%), erosion (n = 138, 13.40%), and impaired healing (n = 49, 4.76%) were most commonly reported to affect patients. Death was reported four times; after expert review, no reports justified the device or procedure as a reasonable cause. Several non-life-threatening ICM complications were commonly noted from the analysis. This study supports the safe use of ICMs. A better understanding of the complication profile will help providers select patients, provide informed consent, and expected management.
Sections du résumé
BACKGROUND
Complications using internal cardiac monitors (ICM) have been reported at a low rate. Targeted analyses of complications have not been well described in the literature.
OBJECTIVE
To investigate and describe complications associated with ICM events reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS
Our team reviewed all reported events for the Reveal LINQ loop recorder submitted to the MAUDE database over 7 years (1/1/2013-12/31/2019). A 5% random selection of reports was audited by two researchers to ensure report validity. Two cardiologists manually reviewed death and incongruent events for final interpretation.
RESULTS
12,652 records were obtained during the observed time period. A total of 15,587 device complications were reported. Of this, undersensing (n = 4509, 28.93%), premature discharge of battery (n = 3262, 20.93%), oversensing (n = 2788, 17.89%), and other sensing issues (n = 1532, 9.83%) were most commonly reported. Patient adverse events were reported 1,030 times. Pain or discomfort (n = 275, 26.70%), site infection (n = 213, 20.68%), erosion (n = 138, 13.40%), and impaired healing (n = 49, 4.76%) were most commonly reported to affect patients. Death was reported four times; after expert review, no reports justified the device or procedure as a reasonable cause.
CONCLUSION
Several non-life-threatening ICM complications were commonly noted from the analysis. This study supports the safe use of ICMs. A better understanding of the complication profile will help providers select patients, provide informed consent, and expected management.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1306-1309Informations de copyright
© 2022 Wiley Periodicals LLC.
Références
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