TPLC - Total Product Life Cycle

show TPLC since

Device	system, hemodynamic, implantable
Product Code	MOM
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
11	6	7	16	24	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Frayed	3282	3282
Incorrect Measurement	2592	2592
Application Program Problem	639	639
Sparking	565	565
Inappropriate Waveform	478	478
Failure to Power Up	422	422
Adverse Event Without Identified Device or Use Problem	249	249
Intermittent Loss of Power	126	126
Failure to Read Input Signal	99	99
Mechanical Problem	94	94
Break	78	78
Loose or Intermittent Connection	67	67
Application Program Freezes, Becomes Nonfunctional	62	62
Migration	61	61
Wireless Communication Problem	59	59
Difficult to Advance	48	48
Electromagnetic Interference	46	46
Unable to Obtain Readings	38	38
Incorrect, Inadequate or Imprecise Result or Readings	38	38
Difficult or Delayed Separation	35	35
Insufficient Information	26	26
Unintended Electrical Shock	24	24
Smoking	23	23
Calibration Problem	22	22
Difficult to Remove	20	20
Failure to Advance	18	18
Thermal Decomposition of Device	18	18
Device Emits Odor	16	16
Positioning Problem	14	14
Melted	13	13
Power Problem	13	13
No Tactile Prompts/Feedback	12	12
Communication or Transmission Problem	11	11
Entrapment of Device	11	11
Device Displays Incorrect Message	11	11
Device Sensing Problem	10	10
Electrical /Electronic Property Problem	9	9
Device Damaged by Another Device	9	9
Noise, Audible	9	9
Overheating of Device	8	8
Failure to Calibrate	8	8
No Apparent Adverse Event	8	8
Unexpected Shutdown	8	8
Activation, Positioning or Separation Problem	7	7
Premature Separation	6	6
Fire	5	5
Improper or Incorrect Procedure or Method	5	5
Failure to Shut Off	5	5
Difficult or Delayed Positioning	5	5
No Display/Image	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7643	7643
Hemoptysis	111	111
Dyspnea	55	55
Insufficient Information	48	48
Hypervolemia	43	43
Heart Failure/Congestive Heart Failure	41	41
Electric Shock	26	26
No Consequences Or Impact To Patient	23	23
Pulmonary Embolism	19	19
Great Vessel Perforation	18	18
Swelling/ Edema	15	15
Low Blood Pressure/ Hypotension	15	15
Cough	14	14
Thrombosis/Thrombus	14	14
Hypovolemia	12	12
Hemorrhage/Bleeding	9	9
Tachycardia	8	8
Chest Pain	8	8
Heart Block	8	8
Foreign Body In Patient	8	8
Dizziness	8	8
Cardiac Arrest	8	8
Perforation	7	7
Pseudoaneurysm	6	6
Renal Impairment	6	6
Cardiac Perforation	6	6
Low Oxygen Saturation	6	6
Syncope/Fainting	6	6
Weight Changes	6	6
Death	6	6
Renal Failure	5	5
Perforation of Vessels	5	5
Presyncope	5	5
Sepsis	5	5
Dehydration	5	5
Pulmonary Edema	4	4
Pericardial Effusion	4	4
Hematoma	4	4
Fatigue	4	4
Pain	4	4
Hypovolemic Shock	3	3
Obstruction/Occlusion	3	3
Embolism/Embolus	3	3
Hemothorax	3	3
Shock	3	3
Bradycardia	3	3
Nausea	3	3
Headache	3	3
Ventricular Fibrillation	3	3
Foreign Body Embolism	3	3