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
Low impedance	10	10
Impedance Problem	10	10
Connection Problem	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
Pacing Problem	4	4
Device Operates Differently Than Expected	4	4
Use of Device Problem	3	3
Under-Sensing	3	3
Pocket Stimulation	3	3
Off-Label Use	2	2
Electrical /Electronic Property Problem	2	2
Appropriate Term/Code Not Available	2	2
High Sensing Threshold	2	2
Noise, Audible	2	2
Human-Device Interface Problem	2	2
Shelf Life Exceeded	2	2
Degraded	2	2
Detachment of Device or Device Component	2	2
Material Separation	2	2
Mechanical Jam	1	1
Electronic Property Issue	1	1
Premature Discharge of Battery	1	1
Loose or Intermittent Connection	1	1
Component(s), broken	1	1
No Apparent Adverse Event	1	1
Difficult To Position	1	1
Retraction Problem	1	1
Failure to Sense	1	1
Therapeutic or Diagnostic Output Failure	1	1
Battery Problem	1	1
Intermittent Capture	1	1
Material Deformation	1	1
Unstable Capture Threshold	1	1
Difficult or Delayed Positioning	1	1
Device Fell	1	1
Device Alarm System	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
Pocket Erosion	5	5
Therapeutic Response, Decreased	5	5
Dizziness	5	5
Hypersensitivity/Allergic reaction	3	3
Syncope	3	3
No Code Available	3	3
Failure of Implant	3	3
No Information	3	3
Hematoma	3	3
Bradycardia	3	3
Chest Pain	3	3
Cardiac Perforation	3	3
Endocarditis	2	2
Undesired Nerve Stimulation	2	2
Fluid Discharge	2	2
Pain	2	2
Discomfort	2	2
Fever	2	2
Seroma	2	2
Pericardial Effusion	2	2
Muscle Stimulation	2	2
Perforation	2	2
Arrhythmia	2	2
Wound Dehiscence	2	2
Therapeutic Response, Increased	2	2
Complaint, Ill-Defined	2	2
Ventricular Fibrillation	1	1
Cardiac Tamponade	1	1
Burning Sensation	1	1
Skin Erosion	1	1
Chills	1	1
Septic Shock	1	1
Palpitations	1	1
No Patient Involvement	1	1
Skin Inflammation	1	1
Atrial Fibrillation	1	1
Head Injury	1	1
Dyspnea	1	1
Heart Failure/Congestive Heart Failure	1	1
Congenital Defect/Deformity	1	1
Necrosis	1	1
Bacterial Infection	1	1