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	1634	1635
Computer Operating System Problem	1068	1069
Communication or Transmission Problem	912	914
Display or Visual Feedback Problem	881	882
Output Problem	267	267
Data Problem	198	200
Failure to Interrogate	126	127
Device Difficult to Program or Calibrate	124	126
Capturing Problem	113	113
Application Program Problem	83	83
Pacing Problem	78	78
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	15
Over-Sensing	11	11
Impedance Problem	11	11
Unexpected Shutdown	10	10
Mechanical Problem	6	6
Loose or Intermittent Connection	4	4
Connection Problem	4	4
Use of Incorrect Control/Treatment Settings	3	3
Under-Sensing	2	2
Use of Device Problem	2	2
Failure to Power Up	2	2
Unable to Obtain Readings	2	4
Material Integrity Problem	2	2
Application Program Version or Upgrade Problem	2	2
Reset Problem	2	2
Appropriate Term/Code Not Available	2	3
High Capture Threshold	2	2
Low impedance	1	1
High impedance	1	1
Inappropriate or Unexpected Reset	1	1
Human-Device Interface Problem	1	1
Loss of Data	1	1
Battery Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Defective Device	1	1
Date/Time-Related Software Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Corroded	1	1
Missing Test Results	1	1
Break	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3378	3381
No Consequences Or Impact To Patient	75	75
No Known Impact Or Consequence To Patient	41	41
Asystole	27	28
Arrhythmia	10	10
No Patient Involvement	9	9
Tachycardia	9	9
Bradycardia	8	8
Cardiac Arrest	7	7
Shock from Patient Lead(s)	6	7
Insufficient Information	5	5
Low Blood Pressure/ Hypotension	5	6
Heart Block	4	4
Unspecified Vascular Problem	4	4
Dizziness	3	3
Failure of Implant	2	2
Presyncope	2	2
Discomfort	2	2
Shock	2	2
Undesired Nerve Stimulation	2	2
Loss of consciousness	2	2
Syncope/Fainting	1	1
Pneumothorax	1	1
Pericardial Effusion	1	1
Atrial Fibrillation	1	1
Cardiac Tamponade	1	1
Pleural Effusion	1	1
Fall	1	1
Pain	1	1