TPLC - Total Product Life Cycle

show TPLC since

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