TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Failure	1918	1918
Loss of or Failure to Bond	244	244
Separation Failure	187	187
Failure to Transmit Record	120	120
Detachment of Device or Device Component	108	108
Entrapment of Device	52	52
Insufficient Information	35	35
Adverse Event Without Identified Device or Use Problem	23	23
Break	22	22
Activation, Positioning or Separation Problem	20	20
Difficult or Delayed Separation	18	18
Unintended Application Program Shut Down	16	16
Activation Failure	13	15
Activation Problem	11	12
Loss of Data	9	9
Premature Separation	8	8
Material Twisted/Bent	7	7
Device Dislodged or Dislocated	6	6
Nonstandard Device	5	7
Device Damaged Prior to Use	5	5
Defective Device	5	5
Therapeutic or Diagnostic Output Failure	5	5
Malposition of Device	4	4
Data Problem	4	4
Unexpected Shutdown	3	3
Physical Resistance/Sticking	3	3
Failure to Advance	3	3
Migration	3	3
Failure to Fire	3	3
Use of Device Problem	3	3
Loss of Power	2	2
Loose or Intermittent Connection	2	2
Connection Problem	2	2
Calibration Problem	2	2
Blocked Connection	2	2
Failure to Power Up	2	2
Device Slipped	2	4
Patient Device Interaction Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Difficult to Remove	2	2
Material Integrity Problem	2	2
Mechanical Problem	2	2
Device Fell	2	2
Unintended Movement	2	2
Premature Activation	1	1
Device Displays Incorrect Message	1	1
Improper or Incorrect Procedure or Method	1	1
Display or Visual Feedback Problem	1	1
Premature Discharge of Battery	1	1
Signal Artifact/Noise	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1047	1051
No Consequences Or Impact To Patient	550	550
Foreign Body In Patient	484	484
Airway Obstruction	381	381
Insufficient Information	71	72
Aspiration/Inhalation	59	59
Injury	36	36
Hemorrhage/Bleeding	33	33
Chest Pain	33	33
Pain	31	31
Laceration(s) of Esophagus	29	29
Unintended Radiation Exposure	24	24
Sedation	17	17
Oversedation	17	17
Cough	14	14
Unspecified Tissue Injury	12	12
No Information	12	12
Sore Throat	11	11
Dysphagia/ Odynophagia	10	10
Failure of Implant	10	10
No Known Impact Or Consequence To Patient	10	12
Discomfort	9	9
Laceration(s)	8	8
No Code Available	8	8
Vomiting	7	7
Radiation Exposure, Unintended	6	6
Blood Loss	5	5
Low Oxygen Saturation	5	5
Dyspnea	4	4
Distress	4	4
Ulcer	3	3
Pyrosis/Heartburn	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Fever	2	2
Asthma	2	2
No Patient Involvement	2	2
Perforation of Esophagus	2	2
Nausea	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Low Blood Pressure/ Hypotension	1	1
Arthritis	1	1
Bacterial Infection	1	1
Device Embedded In Tissue or Plaque	1	1
Respiratory Insufficiency	1	1
Constipation	1	1
Lethargy	1	1
Hypoxia	1	1
Tissue Damage	1	1
Swelling/ Edema	1	1
Gastrointestinal Regurgitation	1	1