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	109	109
High impedance	24	24
Over-Sensing	19	19
Signal Artifact/Noise	18	18
Material Integrity Problem	18	18
High Capture Threshold	18	18
Failure to Capture	17	17
Connection Problem	10	10
Impedance Problem	10	10
Low impedance	10	10
Ambient Noise Problem	9	9
Fracture	9	9
Break	7	7
Insufficient Information	6	6
Device Sensing Problem	5	5
Mechanical Problem	5	5
Device Dislodged or Dislocated	5	5
Capturing Problem	5	5
Pacing Problem	4	4
Device Operates Differently Than Expected	4	4
Use of Device Problem	3	3
Pocket Stimulation	3	3
Under-Sensing	3	3
Material Separation	2	2
Detachment of Device or Device Component	2	2
Human-Device Interface Problem	2	2
Off-Label Use	2	2
High Sensing Threshold	2	2
Noise, Audible	2	2
Shelf Life Exceeded	2	2
Degraded	2	2
Appropriate Term/Code Not Available	2	2
Electrical /Electronic Property Problem	2	2
Retraction Problem	1	1
Difficult To Position	1	1
No Apparent Adverse Event	1	1
Mechanical Jam	1	1
Loose or Intermittent Connection	1	1
Premature Discharge of Battery	1	1
Electronic Property Issue	1	1
Battery Problem	1	1
Intermittent Capture	1	1
Component(s), broken	1	1
Unstable Capture Threshold	1	1
Difficult or Delayed Positioning	1	1
Material Deformation	1	1
Failure to Sense	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Fell	1	1
Device Markings/Labelling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	85	85
No Known Impact Or Consequence To Patient	64	64
No Clinical Signs, Symptoms or Conditions	41	41
No Consequences Or Impact To Patient	25	25
Sepsis	7	7
Insufficient Information	7	7
Erosion	6	6
Death	5	5
Dizziness	5	5
Pocket Erosion	5	5
Therapeutic Response, Decreased	5	5
Syncope	3	3
Hypersensitivity/Allergic reaction	3	3
Failure of Implant	3	3
No Code Available	3	3
No Information	3	3
Hematoma	3	3
Cardiac Perforation	3	3
Chest Pain	3	3
Bradycardia	3	3
Wound Dehiscence	2	2
Arrhythmia	2	2
Therapeutic Response, Increased	2	2
Complaint, Ill-Defined	2	2
Muscle Stimulation	2	2
Perforation	2	2
Pericardial Effusion	2	2
Fever	2	2
Seroma	2	2
Endocarditis	2	2
Undesired Nerve Stimulation	2	2
Discomfort	2	2
Fluid Discharge	2	2
Pain	2	2
Device Embedded In Tissue or Plaque	1	1
Respiratory Failure	1	1
Heart Block	1	1
Bacterial Infection	1	1
Heart Failure/Congestive Heart Failure	1	1
Congenital Defect/Deformity	1	1
Dyspnea	1	1
No Patient Involvement	1	1
Skin Inflammation	1	1
Septic Shock	1	1
Chills	1	1
Burning Sensation	1	1
Ventricular Fibrillation	1	1
Skin Erosion	1	1
Palpitations	1	1
Cardiac Tamponade	1	1