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