TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
8	6	11	6	7	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Frayed	1843	1843
Incorrect Measurement	1665	1665
Device Sensing Problem	579	579
Adverse Event Without Identified Device or Use Problem	406	406
Device Displays Incorrect Message	395	395
Sparking	392	392
Inappropriate Waveform	343	343
Failure to Power Up	285	285
Insufficient Information	112	112
Mechanical Problem	107	107
Intermittent Loss of Power	74	74
Migration	55	55
Failure to Read Input Signal	48	48
Break	48	48
Loose or Intermittent Connection	47	47
Difficult to Advance	43	43
Unable to Obtain Readings	38	38
Wireless Communication Problem	36	36
Application Program Freezes, Becomes Nonfunctional	36	36
Incorrect, Inadequate or Imprecise Result or Readings	29	29
Difficult or Delayed Separation	26	26
Electromagnetic Interference	25	25
Smoking	19	19
Difficult to Remove	19	19
Thermal Decomposition of Device	16	16
Failure to Advance	14	14
Positioning Problem	13	13
Entrapment of Device	11	11
Calibration Problem	11	11
Unintended Electrical Shock	10	10
No Tactile Prompts/Feedback	10	10
Melted	9	9
Power Problem	9	9
Electrical /Electronic Property Problem	7	7
Device Damaged by Another Device	6	6
Failure to Calibrate	6	6
Difficult to Insert	6	6
Device Emits Odor	6	6
No Apparent Adverse Event	6	6
Activation, Positioning or Separation Problem	6	6
Communication or Transmission Problem	6	6
Separation Problem	6	6
Fracture	4	4
Physical Resistance/Sticking	4	4
Failure to Shut Off	4	4
Erratic or Intermittent Display	3	3
Improper or Incorrect Procedure or Method	3	3
Premature Separation	3	3
Application Program Problem	3	3
Unexpected Shutdown	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4286	4286
No Consequences Or Impact To Patient	1139	1139
Death	143	143
Hemoptysis	115	115
Insufficient Information	43	43
Hypervolemia	26	26
Dyspnea	25	25
Heart Failure/Congestive Heart Failure	23	23
Pulmonary Embolism	15	15
Low Blood Pressure/ Hypotension	12	12
Great Vessel Perforation	12	12
Thrombosis/Thrombus	11	11
Electric Shock	10	10
No Known Impact Or Consequence To Patient	10	10
Foreign Body In Patient	9	9
Hypovolemia	8	8
Heart Block	8	8
Hemorrhage/Bleeding	8	8
Chest Pain	8	8
Cardiac Arrest	8	8
Tachycardia	7	7
Ventricular Tachycardia	7	7
Perforation	7	7
Pseudoaneurysm	6	6
Swelling/ Edema	6	6
Renal Failure	6	6
Hematoma	6	6
Arrhythmia	6	6
Sepsis	6	6
Perforation of Vessels	4	4
Shock	4	4
Cardiac Perforation	4	4
Renal Impairment	4	4
Foreign Body Embolism	4	4
Hypovolemic Shock	3	3
Thrombus	3	3
Syncope/Fainting	3	3
Syncope	3	3
Bacterial Infection	3	3
Hypoxia	3	3
Presyncope	3	3
Pulmonary Edema	3	3
Bradycardia	3	3
Pain	3	3
No Patient Involvement	3	3
High Blood Pressure/ Hypertension	2	2
Bruise/Contusion	2	2
Unspecified Infection	2	2
Respiratory Failure	2	2
Low Oxygen Saturation	2	2