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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, hypoglossal nerve, implanted, apnea
Product CodeMNQ
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
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