TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	116	116
Pacing Problem	103	103
Inflation Problem	64	64
Incorrect Measurement	58	58
Deflation Problem	56	56
Incorrect, Inadequate or Imprecise Result or Readings	55	55
Leak/Splash	42	42
Adverse Event Without Identified Device or Use Problem	42	42
Burst Container or Vessel	36	36
Appropriate Term/Code Not Available	32	32
Difficult to Advance	28	28
Detachment of Device or Device Component	27	27
Failure to Capture	27	27
Material Split, Cut or Torn	23	23
Break	22	22
Material Separation	22	22
No Pacing	18	18
Fluid/Blood Leak	17	17
Physical Resistance/Sticking	17	17
Failure to Deflate	16	16
Difficult to Remove	15	15
Material Puncture/Hole	12	12
Material Deformation	10	10
No Device Output	9	9
Difficult or Delayed Positioning	8	8
Unable to Obtain Readings	8	8
Difficult to Insert	8	8
Material Integrity Problem	8	8
Defective Device	8	8
Component Missing	7	7
Obstruction of Flow	6	6
Material Twisted/Bent	6	6
Material Fragmentation	5	5
Insufficient Flow or Under Infusion	5	5
Defective Component	4	4
Therapeutic or Diagnostic Output Failure	4	4
Contamination	4	4
Failure to Advance	4	4
Connection Problem	4	4
Inaccurate Information	4	4
Entrapment of Device	4	4
Use of Device Problem	4	4
Gas/Air Leak	4	4
Activation, Positioning or Separation Problem	4	4
Product Quality Problem	3	3
Insufficient Information	3	3
Patient-Device Incompatibility	3	3
Crack	3	3
High Test Results	3	3
Output Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	519	519
No Consequences Or Impact To Patient	146	146
No Known Impact Or Consequence To Patient	114	114
Insufficient Information	64	64
Hemorrhage/Bleeding	18	18
Vascular Dissection	11	11
Arrhythmia	10	10
No Patient Involvement	10	10
No Code Available	8	8
Great Vessel Perforation	7	7
Low Blood Pressure/ Hypotension	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
No Information	6	6
Hemoptysis	6	6
Cardiac Tamponade	6	6
Cardiac Arrest	6	6
Cardiac Perforation	5	5
Hypersensitivity/Allergic reaction	4	4
Dyspnea	4	4
Device Embedded In Tissue or Plaque	4	4
Needle Stick/Puncture	4	4
Anaphylactic Shock	3	3
Bradycardia	3	3
Pain	3	3
Chest Pain	3	3
Foreign Body In Patient	3	3
Low Oxygen Saturation	3	3
Failure of Implant	3	3
High Blood Pressure/ Hypertension	3	3
Unspecified Vascular Problem	2	2
Aortic Valve Stenosis	2	2
Anaphylactoid	2	2
Rupture	2	2
Atrial Fibrillation	2	2
Perforation	2	2
Respiratory Arrest	2	2
Complaint, Ill-Defined	2	2
Death	2	2
Unspecified Infection	2	2
Extravasation	2	2
Tachycardia	2	2
Perforation of Vessels	2	2
Cough	2	2
Swelling/ Edema	2	2
Therapeutic Effects, Unexpected	1	1
Heart Block	1	1
Atrial Flutter	1	1
Thrombus	1	1
Ectopic Heartbeat	1	1
Pseudoaneurysm	1	1