TPLC - Total Product Life Cycle

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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	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2497	28849
Migration	162	406
Migration or Expulsion of Device	143	875
Device Sensing Problem	102	2542
Expulsion	36	36
Malposition of Device	22	266
Detachment of Device or Device Component	15	15
Failure to Deliver Energy	12	12
Material Twisted/Bent	11	133
Device Dislodged or Dislocated	8	130
Material Split, Cut or Torn	5	5
Impedance Problem	4	4
Positioning Problem	4	4
Improper or Incorrect Procedure or Method	3	247
Patient Device Interaction Problem	3	3
Failure to Deliver Shock/Stimulation	3	3
Defective Device	3	3
Self-Activation or Keying	2	2
Difficult or Delayed Activation	2	2
Unintended Electrical Shock	2	2
Failure to Shut Off	2	2
Energy Output Problem	2	2
Unexpected Deactivation	2	2
Corroded	2	2
Device Appears to Trigger Rejection	2	2
Failure of Device to Self-Test	1	1
Therapeutic or Diagnostic Output Failure	1	1
Fluid/Blood Leak	1	1
Patient-Device Incompatibility	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
High impedance	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Fracture	1	1
Material Puncture/Hole	1	1
Lack of Effect	1	1
Use of Device Problem	1	1
Premature Discharge of Battery	1	1
Intermittent Energy Output	1	1
Output below Specifications	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	871	6727
Unspecified Infection	569	7645
Erosion	302	3596
Hematoma	256	2818
Wound Dehiscence	253	1961
Perforation of Vessels	245	3417
No Clinical Signs, Symptoms or Conditions	166	3338
Headache	159	403
Swelling/ Edema	157	2353
Inflammation	147	513
Speech Disorder	103	469
Purulent Discharge	98	98
Pneumothorax	82	814
Seroma	77	1053
Fluid Discharge	77	77
Dysphagia/ Odynophagia	71	315
Implant Pain	48	48
Neck Pain	46	168
Medical device site infection	42	42
Neuropathy	38	38
Skin Inflammation/ Irritation	37	403
Pocket Erosion	31	153
Hemorrhage/Blood Loss/Bleeding	31	153
Abscess	27	27
Bacterial Infection	27	1735
Twiddlers Syndrome	25	269
Impaired Healing	25	25
Failure of Implant	23	23
Ear Pain	21	21
Nerve Damage	20	142
Cellulitis	20	142
Discomfort	18	20
Sleep Dysfunction	18	18
Insufficient Information	17	17
Foreign Body In Patient	17	749
Numbness	16	16
Burning Sensation	14	14
Rash	14	136
Unspecified Tissue Injury	14	14
Dyspnea	13	13
Nodule	13	13
Sore Throat	12	12
Erythema	12	12
Undesired Nerve Stimulation	12	14
Shock from Patient Lead(s)	12	12
Perforation	11	255
Breathing-related sleep disorder	10	10
Electric Shock	10	10
Voice alteration	9	9
Chest Pain	9	9