TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	114	114
Pacing Problem	96	96
Inflation Problem	64	64
Deflation Problem	56	56
Incorrect, Inadequate or Imprecise Result or Readings	53	53
Incorrect Measurement	50	50
Leak/Splash	42	42
Adverse Event Without Identified Device or Use Problem	40	40
Appropriate Term/Code Not Available	31	31
Burst Container or Vessel	30	30
Difficult to Advance	28	28
Failure to Capture	27	27
Material Split, Cut or Torn	23	23
Detachment of Device or Device Component	23	23
Break	22	22
Material Separation	22	22
Physical Resistance/Sticking	17	17
Fluid/Blood Leak	17	17
Difficult to Remove	15	15
No Pacing	14	14
Failure to Deflate	14	14
Material Puncture/Hole	12	12
Material Deformation	10	10
No Device Output	9	9
Difficult or Delayed Positioning	8	8
Difficult to Insert	8	8
Unable to Obtain Readings	8	8
Defective Device	8	8
Material Integrity Problem	8	8
Component Missing	7	7
Obstruction of Flow	6	6
Material Twisted/Bent	6	6
Material Fragmentation	5	5
Contamination	4	4
Failure to Advance	4	4
Connection Problem	4	4
Inaccurate Information	4	4
Activation, Positioning or Separation Problem	4	4
Use of Device Problem	4	4
Insufficient Flow or Under Infusion	4	4
Entrapment of Device	4	4
Defective Component	4	4
Therapeutic or Diagnostic Output Failure	4	4
Gas/Air Leak	4	4
Crack	3	3
High Test Results	3	3
Patient-Device Incompatibility	3	3
Insufficient Information	3	3
Product Quality Problem	3	3
Device Displays Incorrect Message	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	478	478
No Consequences Or Impact To Patient	146	146
No Known Impact Or Consequence To Patient	114	114
Insufficient Information	60	60
Hemorrhage/Bleeding	17	17
Vascular Dissection	11	11
Arrhythmia	10	10
No Patient Involvement	10	10
No Code Available	8	8
Low Blood Pressure/ Hypotension	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Great Vessel Perforation	6	6
No Information	6	6
Cardiac Tamponade	6	6
Cardiac Arrest	6	6
Cardiac Perforation	5	5
Device Embedded In Tissue or Plaque	4	4
Hypersensitivity/Allergic reaction	4	4
Hemoptysis	4	4
Dyspnea	4	4
Needle Stick/Puncture	4	4
High Blood Pressure/ Hypertension	3	3
Failure of Implant	3	3
Anaphylactic Shock	3	3
Bradycardia	3	3
Pain	3	3
Chest Pain	3	3
Foreign Body In Patient	3	3
Low Oxygen Saturation	2	2
Aortic Valve Stenosis	2	2
Unspecified Vascular Problem	2	2
Tachycardia	2	2
Perforation of Vessels	2	2
Swelling/ Edema	2	2
Extravasation	2	2
Rupture	2	2
Anaphylactoid	2	2
Atrial Fibrillation	2	2
Perforation	2	2
Respiratory Arrest	2	2
Death	2	2
Complaint, Ill-Defined	2	2
Unspecified Infection	2	2
Exposure to Body Fluids	1	1
Injury	1	1
Fever	1	1
Septic Shock	1	1
Complete Heart Block	1	1
Cardiopulmonary Arrest	1	1
Blood Loss	1	1