TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	102	102
High impedance	22	22
Material Integrity Problem	18	18
Over-Sensing	18	18
Signal Artifact/Noise	16	16
Failure to Capture	15	15
High Capture Threshold	15	15
Impedance Problem	10	10
Low impedance	10	10
Connection Problem	10	10
Fracture	9	9
Ambient Noise Problem	9	9
Break	7	7
Mechanical Problem	5	5
Capturing Problem	5	5
Device Dislodged or Dislocated	5	5
Device Operates Differently Than Expected	4	4
Device Sensing Problem	4	4
Insufficient Information	4	4
Pacing Problem	3	3
Under-Sensing	3	3
Pocket Stimulation	3	3
Use of Device Problem	3	3
Appropriate Term/Code Not Available	2	2
Degraded	2	2
Electrical /Electronic Property Problem	2	2
High Sensing Threshold	2	2
Human-Device Interface Problem	2	2
Material Separation	2	2
Off-Label Use	2	2
Noise, Audible	2	2
Shelf Life Exceeded	2	2
Detachment of Device or Device Component	2	2
Difficult To Position	1	1
Component(s), broken	1	1
Intermittent Capture	1	1
Device Alarm System	1	1
Loose or Intermittent Connection	1	1
Device Markings/Labelling Problem	1	1
Mechanical Jam	1	1
Unstable Capture Threshold	1	1
Material Deformation	1	1
Failure to Sense	1	1
Device Fell	1	1
Electronic Property Issue	1	1
Battery Problem	1	1
Difficult or Delayed Positioning	1	1
Premature Discharge of Battery	1	1
Retraction Problem	1	1
No Apparent Adverse Event	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	79	79
No Known Impact Or Consequence To Patient	64	64
No Clinical Signs, Symptoms or Conditions	34	34
No Consequences Or Impact To Patient	25	25
Sepsis	7	7
Insufficient Information	7	7
Erosion	6	6
Death	5	5
Therapeutic Response, Decreased	5	5
Pocket Erosion	4	4
Dizziness	3	3
Hematoma	3	3
Chest Pain	3	3
Failure of Implant	3	3
Syncope	3	3
Cardiac Perforation	3	3
No Information	3	3
No Code Available	3	3
Pericardial Effusion	2	2
Fluid Discharge	2	2
Therapeutic Response, Increased	2	2
Complaint, Ill-Defined	2	2
Wound Dehiscence	2	2
Muscle Stimulation	2	2
Hypersensitivity/Allergic reaction	2	2
Endocarditis	2	2
Seroma	2	2
Undesired Nerve Stimulation	2	2
Pain	2	2
Perforation	2	2
Pneumothorax	1	1
Septic Shock	1	1
Necrosis	1	1
Skin Erosion	1	1
Ventricular Fibrillation	1	1
Burning Sensation	1	1
Cardiac Tamponade	1	1
Fever	1	1
Head Injury	1	1
Dyspnea	1	1
Bradycardia	1	1
Arrhythmia	1	1
Atrial Fibrillation	1	1
Bacterial Infection	1	1
Skin Inflammation	1	1
Palpitations	1	1
Respiratory Failure	1	1
Discomfort	1	1
No Patient Involvement	1	1
Device Embedded In Tissue or Plaque	1	1
Heart Block	1	1
Heart Failure/Congestive Heart Failure	1	1