TPLC - Total Product Life Cycle

• Device: stimulator, hypoglossal nerve, implanted, apnea
• Product Code: MNQ
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
9	16	12	13	13	7

MDR Year	MDR Reports	MDR Events
2019	92	214
2020	79	445
2021	218	6806
2022	283	23951
2023	460	460
2024	283	283

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1159	27755
Device Sensing Problem	79	2519
Migration or Expulsion of Device	42	1018
Malposition of Device	31	275
Migration	30	274
Detachment of Device or Device Component	11	11
Improper or Incorrect Procedure or Method	10	254
Therapeutic or Diagnostic Output Failure	8	8
Insufficient Information	8	8
Positioning Problem	6	6
Patient Device Interaction Problem	6	6
Expulsion	3	3
Impedance Problem	3	3
Use of Device Problem	3	3
Appropriate Term/Code Not Available	3	3
Signal Artifact/Noise	1	1
No Apparent Adverse Event	1	1
Device Dislodged or Dislocated	1	123
Material Split, Cut or Torn	1	1
Electrical Power Problem	1	1
Self-Activation or Keying	1	1
Lack of Effect	1	1
Activation Failure	1	1
Electromagnetic Compatibility Problem	1	1
Battery Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Material Twisted/Bent	1	123
Unintended Electrical Shock	1	1
Fracture	1	1
Disconnection	1	1
No Device Output	1	1
Calibration Problem	1	1
Failure to Shut Off	1	1
Output Problem	1	1
Defective Device	1	1
Break	1	1
Positioning Failure	1	1
Unexpected Shutdown	1	1
Application Program Problem	1	1
Electromagnetic Interference	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	307	6163
Unspecified Infection	263	7339
Perforation of Vessels	149	3321
Erosion	130	3668
Hematoma	124	2686
Wound Dehiscence	91	1799
No Clinical Signs, Symptoms or Conditions	88	3260
Swelling/ Edema	77	2273
Bacterial Infection	60	2256
Pneumothorax	60	792
Seroma	38	1014
Headache	29	273
Hemorrhage/Bleeding	22	144
Speech Disorder	21	387
Inflammation	18	384
Skin Inflammation/ Irritation	15	381
Foreign Body In Patient	15	747
Dysphagia/ Odynophagia	14	258
No Known Impact Or Consequence To Patient	12	12
Nerve Damage	11	133
Burning Sensation	11	11
Neck Pain	10	132
Insufficient Information	10	10
Cellulitis	9	131
Failure of Implant	8	8
Twiddlers Syndrome	8	252
No Code Available	8	8
Fluid Discharge	7	7
Purulent Discharge	7	7
Abscess	7	7
Rash	7	129
Erythema	6	6
Device Embedded In Tissue or Plaque	6	128
Fever	5	127
Dyspnea	5	5
Perforation	5	249
Undesired Nerve Stimulation	4	4
Dysphasia	4	4
Discomfort	4	4
Twiddlers Syndrome	4	4
Nausea	4	4
Thrombosis/Thrombus	4	4
Sleep Dysfunction	4	4
Post Operative Wound Infection	4	248
Unspecified Tissue Injury	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Airway Obstruction	3	3
Bruise/Contusion	3	3
Tissue Damage	3	3
Paralysis	3	3
Loss of Range of Motion	3	125
Swelling	3	3
Swollen Glands	2	2
Skin Irritation	2	2
Device Overstimulation of Tissue	2	2
Local Reaction	2	2
Pleural Effusion	2	2
Pocket Erosion	2	124
Pulmonary Edema	2	2
Transient Ischemic Attack	2	124
Numbness	2	2
Impaired Healing	2	2
Anxiety	2	2
Apnea	2	2
Aspiration/Inhalation	2	2
Emotional Changes	2	2
Facial Nerve Paralysis	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Shock from Patient Lead(s)	2	2
Electric Shock	2	2
Tissue Breakdown	2	2
Ambulation Difficulties	1	1
Vascular Dissection	1	1
Nervous System Injury	1	1
Blood Loss	1	1
Bronchospasm	1	1
Weight Changes	1	1
Choking	1	1
Palpitations	1	1
Low Oxygen Saturation	1	1
Lymphoma	1	1
Convulsion/Seizure	1	123
Cough	1	1
Respiratory Arrest	1	123
Unspecified Respiratory Problem	1	123
Physical Asymmetry	1	1
Subcutaneous Nodule	1	1
Nodule	1	1
Suicidal Ideation	1	1
Fatigue	1	1
Fistula	1	123
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Laceration(s)	1	1
Muscle Weakness	1	1
Hearing Impairment	1	1
Infiltration into Tissue	1	1
Encephalopathy	1	1
Stroke/CVA	1	1
Chest Pain	1	1