Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Back to Search Results
Device
stimulator, hypoglossal nerve, implanted, apnea
Product Code
MNQ
Device Class
3
Premarket Approvals (PMA)
2021
2022
2023
2024
2025
2026
12
13
13
12
17
2
MDR Year
MDR Reports
MDR Events
2021
218
6808
2022
283
23951
2023
460
460
2024
697
697
2025
960
960
2026
105
105
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2237
28589
Migration or Expulsion of Device
116
848
Migration
107
351
Device Sensing Problem
100
2540
Malposition of Device
20
264
Inappropriate/Inadequate Shock/Stimulation
16
16
Detachment of Device or Device Component
14
14
Therapeutic or Diagnostic Output Failure
13
13
Defective Device
8
8
Material Twisted/Bent
8
130
Patient Device Interaction Problem
8
10
Improper or Incorrect Procedure or Method
7
251
Device Dislodged or Dislocated
7
129
Use of Device Problem
5
5
Positioning Problem
5
5
Nonstandard Device
4
4
Impedance Problem
4
4
Unintended Electrical Shock
4
4
Break
3
3
Patient-Device Incompatibility
3
3
Self-Activation or Keying
3
3
Material Split, Cut or Torn
3
3
Appropriate Term/Code Not Available
3
3
Fracture
2
2
Application Program Problem
2
2
Unexpected Therapeutic Results
2
2
Lack of Effect
2
2
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Puncture/Hole
1
1
Overheating of Device
1
1
No Device Output
1
1
Loose or Intermittent Connection
1
1
Leak/Splash
1
1
Telemetry Discrepancy
1
1
Material Separation
1
1
Intermittent Energy Output
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Activation Failure
1
1
Insufficient Information
1
1
Unintended Movement
1
1
Output Problem
1
1
Material Protrusion/Extrusion
1
1
Material Integrity Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Failure to Shut Off
1
1
Fail-Safe Problem
1
1
Electromagnetic Compatibility Problem
1
1
Electrical Power Problem
1
1
Communication or Transmission Problem
1
1
Calibration Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
777
6633
Unspecified Infection
526
7602
Erosion
271
3565
Perforation of Vessels
235
3407
Hematoma
231
2793
Wound Dehiscence
212
1920
No Clinical Signs, Symptoms or Conditions
146
3318
Headache
132
376
Swelling/ Edema
130
2326
Inflammation
114
480
Speech Disorder
82
448
Pneumothorax
81
813
Purulent Discharge
75
75
Seroma
67
1043
Dysphagia/ Odynophagia
61
305
Fluid Discharge
59
59
Skin Inflammation/ Irritation
35
401
Neck Pain
34
156
Hemorrhage/Bleeding
28
150
Bacterial Infection
26
1734
Abscess
24
24
Failure of Implant
21
21
Twiddlers Syndrome
20
264
Impaired Healing
19
19
Nerve Damage
18
140
Neuropathy
17
17
Insufficient Information
16
16
Cellulitis
16
138
Sleep Dysfunction
16
16
Foreign Body In Patient
15
747
Numbness
13
13
Discomfort
13
15
Burning Sensation
13
13
Erythema
11
11
Perforation
11
255
Nodule
11
11
Undesired Nerve Stimulation
10
12
Dyspnea
9
9
Shock from Patient Lead(s)
9
9
Muscle Weakness
9
9
Rash
9
131
Electric Shock
9
9
Nausea
8
8
Local Reaction
8
8
Glossitis
7
7
Fever
7
129
Sore Throat
6
6
Paralysis
6
6
Anxiety
6
6
Device Overstimulation of Tissue
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Inspire Medical Systems Inc.
II
Oct-09-2024
2
Inspire Medical Systems Inc.
I
Jun-21-2024
-
-