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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 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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