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	69	69
Over-Sensing	12	12
High Capture Threshold	11	11
Signal Artifact/Noise	7	7
High impedance	6	6
Failure to Capture	6	6
Low impedance	6	6
Ambient Noise Problem	5	5
Device Sensing Problem	5	5
Insufficient Information	4	4
Degraded	4	4
Break	3	3
Use of Device Problem	3	3
Pacing Problem	3	3
Appropriate Term/Code Not Available	3	3
Off-Label Use	2	2
Under-Sensing	2	2
Connection Problem	2	2
Capturing Problem	2	2
Device Alarm System	1	2
Failure to Sense	1	1
Therapeutic or Diagnostic Output Failure	1	1
Patient Device Interaction Problem	1	1
Battery Problem	1	1
Impedance Problem	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Fracture	1	1
Pocket Stimulation	1	1
High Sensing Threshold	1	1
Premature Discharge of Battery	1	2
Loose or Intermittent Connection	1	1
Mechanical Jam	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	58	58
No Clinical Signs, Symptoms or Conditions	54	56
Insufficient Information	9	9
Failure of Implant	6	6
Discomfort	5	5
Fever	4	4
Erythema	4	4
Swelling/ Edema	4	4
Endocarditis	4	4
Pocket Erosion	4	4
Sepsis	3	3
Dizziness	3	3
Purulent Discharge	3	3
Wound Dehiscence	2	2
Arrhythmia	2	2
Pain	2	2
Bradycardia	2	2
Fluid Discharge	2	2
Bacterial Infection	2	2
Erosion	2	2
Hypersensitivity/Allergic reaction	1	1
Presyncope	1	1
Hematoma	1	1
Pericardial Effusion	1	1
Cardiac Tamponade	1	1
Skin Erosion	1	1
Chills	1	1
Cardiac Perforation	1	1
Congenital Defect/Deformity	1	1
Heart Failure/Congestive Heart Failure	1	1
Heart Block	1	1
Respiratory Failure	1	1
Device Embedded In Tissue or Plaque	1	1