TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2018	2019	2020	2021	2022	2023
6	9	16	12	13	4

MDR Year	MDR Reports	MDR Events
2018	54	54
2019	92	214
2020	79	445
2021	218	6806
2022	283	23951
2023	138	138

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	631	27227
Device Sensing Problem	64	2504
Migration or Expulsion of Device	42	1018
Malposition of Device	31	275
Migration	23	145
Appropriate Term/Code Not Available	13	13
Detachment of Device or Device Component	11	11
Insufficient Information	11	11
Improper or Incorrect Procedure or Method	10	254
Patient Device Interaction Problem	8	8
Positioning Problem	7	7
Therapeutic or Diagnostic Output Failure	5	5
Use of Device Problem	4	4
No Apparent Adverse Event	3	3
Impedance Problem	3	3
Expulsion	3	3
Electrical /Electronic Property Problem	3	3
Material Split, Cut or Torn	2	2
Unintended Electrical Shock	1	1
Unexpected Shutdown	1	1
Lack of Effect	1	1
Missing Value Reason	1	1
Activation Failure	1	1
Fracture	1	1
Failure to Calibrate	1	1
Defective Device	1	1
Application Program Problem	1	1
Battery Problem	1	1
Calibration Problem	1	1
Self-Activation or Keying	1	1
Material Separation	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Signal Artifact/Noise	1	1
Break	1	1
Positioning Failure	1	1
Disconnection	1	1
Electromagnetic Interference	1	1
Failure to Shut Off	1	1
Device Operates Differently Than Expected	1	1
Device Dislodged or Dislocated	1	123
Electrical Power Problem	1	1
Electromagnetic Compatibility Problem	1	1
Material Twisted/Bent	1	123
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	156	7232
Pain	133	5989
Perforation of Vessels	90	3262
Erosion	82	3620
Hematoma	70	2632
No Clinical Signs, Symptoms or Conditions	63	3235
Bacterial Infection	62	2258
Wound Dehiscence	45	1753
Pneumothorax	38	770
Swelling/ Edema	33	2107
Seroma	19	995
No Code Available	18	18
Foreign Body In Patient	14	746
No Known Impact Or Consequence To Patient	14	14
Post Operative Wound Infection	10	254
Inflammation	9	375
Neck Pain	7	129
Cellulitis	6	128
Dysphagia/ Odynophagia	6	250
Insufficient Information	6	6
Twiddlers Syndrome	5	5
Burning Sensation	5	5
Tissue Damage	5	5
Swelling	4	4
Rash	4	126
Dysphasia	4	4
Sleep Dysfunction	4	4
Dyspnea	4	4
Headache	4	248
Undesired Nerve Stimulation	4	4
Skin Inflammation/ Irritation	4	370
Twiddlers Syndrome	4	248
Device Embedded In Tissue or Plaque	4	126
Speech Disorder	4	370
Thrombosis/Thrombus	3	3
Tissue Breakdown	3	3
Perforation	3	247
Failure of Implant	3	3
Hemorrhage/Bleeding	3	125
Facial Nerve Paralysis	3	3
Purulent Discharge	3	3
Bruise/Contusion	3	3
Discomfort	3	3
Blood Loss	2	2
Patient Problem/Medical Problem	2	2
Nerve Damage	2	2
Skin Irritation	2	2
Pocket Erosion	2	124
Pulmonary Edema	2	2
Loss of Range of Motion	2	124
Swollen Glands	2	2
Transient Ischemic Attack	2	124
Abscess	2	2
Apnea	2	2
Aspiration/Inhalation	2	2
Hypersensitivity/Allergic reaction	2	2
Pleural Effusion	2	2
Neuropathy	2	2
Shock from Patient Lead(s)	2	2
Not Applicable	1	1
No Information	1	1
Respiratory Arrest	1	123
Unspecified Respiratory Problem	1	123
Lymphoma	1	1
Convulsion/Seizure	1	123
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Infiltration into Tissue	1	1
Paralysis	1	1
Laceration(s)	1	1
Muscle Spasm(s)	1	1
Muscle Weakness	1	1
Nausea	1	1
Atrial Fibrillation	1	1
Cardiac Arrest	1	1
Fever	1	123
Fistula	1	123
Hearing Impairment	1	1
Encephalopathy	1	1
Erythema	1	1
Thrombosis	1	1
Twitching	1	1
Dizziness	1	1
Weakness	1	1
Vascular Dissection	1	1
Bronchospasm	1	1
Electric Shock	1	1
Joint Dislocation	1	1
Impaired Healing	1	1
Inadequate Pain Relief	1	1
Sore Throat	1	1
Palpitations	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Inspire Medical Systems Inc.	II	Sep-04-2018