TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Pacing Problem	116	116
Incorrect Measurement	94	94
Material Rupture	93	93
Incorrect, Inadequate or Imprecise Result or Readings	60	61
Deflation Problem	48	48
Inflation Problem	47	47
Burst Container or Vessel	45	45
Leak/Splash	41	41
Adverse Event Without Identified Device or Use Problem	41	41
Fluid/Blood Leak	37	37
Failure to Deflate	31	32
Detachment of Device or Device Component	31	31
Material Split, Cut or Torn	27	28
Difficult to Advance	23	23
No Pacing	22	22
Material Fragmentation	19	19
Material Separation	14	14
Difficult to Remove	13	13
Break	12	12
Material Deformation	11	11
Failure to Capture	10	10
No Device Output	8	8
Difficult or Delayed Positioning	8	8
Physical Resistance/Sticking	8	8
Material Puncture/Hole	8	8
Defective Device	7	7
Obstruction of Flow	7	7
Appropriate Term/Code Not Available	7	7
Unable to Obtain Readings	6	6
Material Integrity Problem	5	5
Contamination	5	5
Crack	5	5
Difficult to Insert	4	4
Separation Problem	3	3
Unintended Deflation	3	3
High Readings	3	3
Air/Gas in Device	3	3
Insufficient Information	3	3
Malposition of Device	3	3
Component Missing	3	4
Gas/Air Leak	3	3
Material Twisted/Bent	3	3
Capturing Problem	3	3
Inaccurate Information	3	3
Therapeutic or Diagnostic Output Failure	2	3
Pressure Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Tear, Rip or Hole in Device Packaging	2	2
Backflow	2	2
Use of Device Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	794	797
Insufficient Information	70	70
Hemorrhage/Bleeding	20	21
Cardiac Tamponade	9	9
Low Blood Pressure/ Hypotension	7	7
Hemoptysis	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Cardiac Arrest	6	6
Cardiac Perforation	6	6
Great Vessel Perforation	5	5
Needle Stick/Puncture	4	4
Vascular Dissection	3	3
Perforation	3	3
Failure of Implant	3	3
Dyspnea	3	3
Bradycardia	3	3
Perforation of Vessels	3	3
Arrhythmia	3	3
Low Oxygen Saturation	3	3
No Information	2	2
Respiratory Arrest	2	2
Foreign Body In Patient	2	2
Pain	2	2
Anaphylactic Shock	2	2
Extravasation	2	2
Tachycardia	2	2
Cough	2	2
Swelling/ Edema	2	2
Pseudoaneurysm	2	2
Unspecified Vascular Problem	2	2
Bronchial Hemorrhage	1	1
Tricuspid Valve Insufficiency/ Regurgitation	1	1
Embolism/Embolus	1	1
Atrial Fibrillation	1	1
Rupture	1	1
Thrombosis/Thrombus	1	1
Hypersensitivity/Allergic reaction	1	1
Chest Pain	1	1
Discomfort	1	1
Physical Entrapment	1	1
Ectopic Heartbeat	1	1
No Consequences Or Impact To Patient	1	1
Heart Block	1	1