TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pacing Problem	124	124
Material Rupture	106	107
Incorrect Measurement	87	87
Incorrect, Inadequate or Imprecise Result or Readings	66	66
Deflation Problem	57	57
Inflation Problem	54	54
Burst Container or Vessel	47	47
Adverse Event Without Identified Device or Use Problem	41	41
Leak/Splash	41	41
Detachment of Device or Device Component	37	37
Fluid/Blood Leak	36	36
Failure to Deflate	29	29
Material Split, Cut or Torn	27	27
Difficult to Advance	25	25
No Pacing	22	22
Material Separation	20	20
Break	19	19
Material Fragmentation	16	16
Difficult to Remove	14	14
Material Deformation	12	12
Failure to Capture	12	12
No Device Output	12	12
Physical Resistance/Sticking	11	11
Material Puncture/Hole	9	9
Appropriate Term/Code Not Available	9	9
Unable to Obtain Readings	9	9
Material Integrity Problem	8	8
Difficult or Delayed Positioning	8	8
Defective Device	7	7
Obstruction of Flow	7	7
Crack	5	5
Difficult to Insert	5	5
Component Missing	5	6
Material Twisted/Bent	5	5
Failure to Advance	4	4
Contamination	4	4
Connection Problem	4	4
Activation, Positioning or Separation Problem	4	4
Insufficient Information	3	3
Tear, Rip or Hole in Device Packaging	3	3
Therapeutic or Diagnostic Output Failure	3	4
Inaccurate Information	3	3
Malposition of Device	3	3
Separation Problem	3	3
Gas/Air Leak	3	3
Device Contamination with Chemical or Other Material	2	2
Capturing Problem	2	2
Insufficient Flow or Under Infusion	2	2
Use of Device Problem	2	2
Disconnection	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	750	751
Insufficient Information	71	71
No Consequences Or Impact To Patient	66	67
No Known Impact Or Consequence To Patient	40	40
Hemorrhage/Bleeding	18	18
Cardiac Tamponade	9	9
Hemoptysis	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Low Blood Pressure/ Hypotension	6	6
Cardiac Arrest	6	6
Great Vessel Perforation	6	6
Cardiac Perforation	6	6
No Patient Involvement	6	6
Vascular Dissection	5	5
No Information	5	5
Needle Stick/Puncture	4	4
Low Oxygen Saturation	3	3
Perforation	3	3
Failure of Implant	3	3
Arrhythmia	3	3
Perforation of Vessels	3	3
Dyspnea	3	3
Bradycardia	3	3
Device Embedded In Tissue or Plaque	2	2
Aortic Valve Stenosis	2	2
Unspecified Vascular Problem	2	2
Pseudoaneurysm	2	2
Swelling/ Edema	2	2
Cough	2	2
Tachycardia	2	2
Extravasation	2	2
Anaphylactic Shock	2	2
Pain	2	2
Foreign Body In Patient	2	2
Rupture	2	2
Respiratory Arrest	2	2
Physical Entrapment	1	1
Discomfort	1	1
Chest Pain	1	1
Thrombosis/Thrombus	1	1
Hypersensitivity/Allergic reaction	1	1
Complete Heart Block	1	1
Ectopic Heartbeat	1	1
High Blood Pressure/ Hypertension	1	1
Atrial Fibrillation	1	1
Heart Block	1	1
Embolism/Embolus	1	1
Tricuspid Valve Insufficiency/ Regurgitation	1	1
Thrombus	1	1
Bronchial Hemorrhage	1	1