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TPLC
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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
4
MDR Year
MDR Reports
MDR Events
2021
218
6808
2022
283
23951
2023
460
460
2024
697
697
2025
960
960
2026
194
194
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2293
28645
Migration or Expulsion of Device
132
864
Migration
117
361
Device Sensing Problem
101
2541
Malposition of Device
20
264
Inappropriate/Inadequate Shock/Stimulation
18
18
Detachment of Device or Device Component
14
14
Therapeutic or Diagnostic Output Failure
14
14
Device Dislodged or Dislocated
8
130
Material Twisted/Bent
8
130
Patient Device Interaction Problem
8
10
Defective Device
8
8
Improper or Incorrect Procedure or Method
7
251
Use of Device Problem
5
5
Positioning Problem
5
5
Nonstandard Device
4
4
Material Split, Cut or Torn
4
4
Unintended Electrical Shock
4
4
Impedance Problem
4
4
Self-Activation or Keying
3
3
Appropriate Term/Code Not Available
3
3
Patient-Device Incompatibility
3
3
Break
3
3
Failure to Deliver Energy
3
3
Lack of Effect
2
2
Application Program Problem
2
2
Fracture
2
2
Unexpected Therapeutic Results
2
2
Corroded
2
2
Insufficient Information
1
1
Material Integrity Problem
1
1
Unintended Movement
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Material Puncture/Hole
1
1
Battery Problem
1
1
Fail-Safe Problem
1
1
Intermittent Energy Output
1
1
Electrical Power Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Calibration Problem
1
1
Electromagnetic Compatibility Problem
1
1
Unintended Power Up
1
1
Output Problem
1
1
Communication or Transmission Problem
1
1
Material Separation
1
1
Telemetry Discrepancy
1
1
Device Contamination with Chemical or Other Material
1
1
Material Protrusion/Extrusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
805
6661
Unspecified Infection
540
7616
Erosion
286
3580
Perforation of Vessels
239
3411
Hematoma
233
2795
Wound Dehiscence
222
1930
No Clinical Signs, Symptoms or Conditions
149
3321
Headache
139
383
Swelling/ Edema
135
2331
Inflammation
124
490
Speech Disorder
88
454
Purulent Discharge
82
82
Pneumothorax
81
813
Seroma
68
1044
Dysphagia/ Odynophagia
63
307
Fluid Discharge
60
60
Neck Pain
35
157
Skin Inflammation/ Irritation
35
401
Hemorrhage/Bleeding
29
151
Bacterial Infection
26
1734
Abscess
24
24
Neuropathy
23
23
Twiddlers Syndrome
22
266
Failure of Implant
21
21
Impaired Healing
19
19
Nerve Damage
18
140
Cellulitis
17
139
Insufficient Information
17
17
Sleep Dysfunction
16
16
Foreign Body In Patient
16
748
Numbness
13
13
Burning Sensation
13
13
Discomfort
13
15
Perforation
11
255
Dyspnea
11
11
Erythema
11
11
Nodule
11
11
Electric Shock
10
10
Undesired Nerve Stimulation
10
12
Rash
10
132
Muscle Weakness
9
9
Shock from Patient Lead(s)
9
9
Nausea
8
8
Local Reaction
8
8
Fever
7
129
Glossitis
7
7
Anxiety
6
6
Sore Throat
6
6
Bruise/Contusion
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
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