TPLC - Total Product Life Cycle

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Device	analyzer, pacemaker generator function
Regulation Description	Pacemaker generator function analyzer.
Product Code	DTC
Regulation Number	870.3630
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	1641	1641
Computer Operating System Problem	1094	1094
Communication or Transmission Problem	925	925
Display or Visual Feedback Problem	887	887
Output Problem	268	268
Data Problem	196	196
Failure to Interrogate	126	126
Device Difficult to Program or Calibrate	124	124
Capturing Problem	115	115
Application Program Problem	83	83
Pacing Problem	80	80
Device Sensing Problem	70	70
Inadequate User Interface	60	60
Wireless Communication Problem	28	28
Problem with Software Installation	26	26
Device Displays Incorrect Message	25	25
Power Problem	19	19
Failure to Capture	18	18
Signal Artifact/Noise	17	17
Inappropriate/Inadequate Shock/Stimulation	14	14
Impedance Problem	11	11
Over-Sensing	11	11
Unexpected Shutdown	10	10
Mechanical Problem	6	6
Loose or Intermittent Connection	6	6
Connection Problem	3	3
Unable to Obtain Readings	2	2
Failure to Power Up	2	2
Material Integrity Problem	2	2
Application Program Version or Upgrade Problem	2	2
Under-Sensing	2	2
Appropriate Term/Code Not Available	2	2
Reset Problem	2	2
High Capture Threshold	2	2
Therapeutic or Diagnostic Output Failure	1	1
Battery Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
High impedance	1	1
Break	1	1
Low impedance	1	1
Human-Device Interface Problem	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3412	3412
No Consequences Or Impact To Patient	75	75
No Known Impact Or Consequence To Patient	41	41
Asystole	27	27
Arrhythmia	9	9
No Patient Involvement	9	9
Tachycardia	9	9
Bradycardia	8	8
Cardiac Arrest	7	7
Shock from Patient Lead(s)	6	6
Low Blood Pressure/ Hypotension	5	5
Heart Block	4	4
Dizziness	3	3
Insufficient Information	3	3
Presyncope	2	2
Discomfort	2	2
Undesired Nerve Stimulation	2	2
Shock	2	2
Loss of consciousness	2	2
Syncope/Fainting	1	1
Pneumothorax	1	1
Atrial Fibrillation	1	1
Pericardial Effusion	1	1
Cardiac Tamponade	1	1
Pleural Effusion	1	1
Fall	1	1
Pain	1	1