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
Material Separation	22	22
Break	22	22
Physical Resistance/Sticking	17	17
Fluid/Blood Leak	17	17
Difficult to Remove	15	15
Failure to Deflate	14	14
No Pacing	14	14
Material Puncture/Hole	12	12
Material Deformation	10	10
No Device Output	9	9
Unable to Obtain Readings	8	8
Difficult to Insert	8	8
Difficult or Delayed Positioning	8	8
Material Integrity Problem	8	8
Defective Device	8	8
Component Missing	7	7
Material Twisted/Bent	6	6
Obstruction of Flow	6	6
Material Fragmentation	5	5
Entrapment of Device	4	4
Therapeutic or Diagnostic Output Failure	4	4
Defective Component	4	4
Insufficient Flow or Under Infusion	4	4
Activation, Positioning or Separation Problem	4	4
Failure to Advance	4	4
Connection Problem	4	4
Gas/Air Leak	4	4
Use of Device Problem	4	4
Contamination	4	4
Inaccurate Information	4	4
High Test Results	3	3
Output Problem	3	3
Device Displays Incorrect Message	3	3
Insufficient Information	3	3
Patient-Device Incompatibility	3	3
Product Quality Problem	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
Great Vessel Perforation	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
No Information	6	6
Cardiac Arrest	6	6
Cardiac Tamponade	6	6
Cardiac Perforation	5	5
Hypersensitivity/Allergic reaction	4	4
Device Embedded In Tissue or Plaque	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
Swelling/ Edema	2	2
Perforation of Vessels	2	2
Tachycardia	2	2
Extravasation	2	2
Unspecified Vascular Problem	2	2
Aortic Valve Stenosis	2	2
Anaphylactoid	2	2
Rupture	2	2
Atrial Fibrillation	2	2
Perforation	2	2
Low Oxygen Saturation	2	2
Respiratory Arrest	2	2
Complaint, Ill-Defined	2	2
Death	2	2
Unspecified Infection	2	2
Therapeutic Effects, Unexpected	1	1
Heart Block	1	1
Ectopic Heartbeat	1	1
Pseudoaneurysm	1	1
Atrial Flutter	1	1
Tissue Damage	1	1
Myocardial Infarction	1	1