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	1680	1681
Computer Operating System Problem	1087	1088
Communication or Transmission Problem	949	951
Display or Visual Feedback Problem	906	907
Output Problem	275	275
Data Problem	203	205
Device Difficult to Program or Calibrate	133	135
Failure to Interrogate	126	127
Capturing Problem	113	113
Pacing Problem	88	88
Application Program Problem	84	84
Device Sensing Problem	83	83
Inadequate User Interface	64	64
Wireless Communication Problem	29	29
Problem with Software Installation	26	26
Device Displays Incorrect Message	25	25
Failure to Capture	21	21
Power Problem	19	19
Signal Artifact/Noise	17	17
Inappropriate/Inadequate Shock/Stimulation	14	15
Impedance Problem	14	14
Over-Sensing	12	12
Unexpected Shutdown	11	11
Under-Sensing	6	6
Mechanical Problem	6	6
High impedance	5	5
Loose or Intermittent Connection	4	4
Connection Problem	4	4
Use of Incorrect Control/Treatment Settings	3	3
Unable to Obtain Readings	3	5
High Capture Threshold	2	2
Appropriate Term/Code Not Available	2	3
Reset Problem	2	2
Material Integrity Problem	2	2
Battery Problem	2	2
Application Program Version or Upgrade Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Failure to Power Up	2	2
Use of Device Problem	2	2
Human-Device Interface Problem	1	1
Loss of Data	1	1
Inappropriate or Unexpected Reset	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
Break	1	1
Low impedance	1	1
Missing Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3389	3392
No Known Impact Or Consequence To Patient	170	170
No Consequences Or Impact To Patient	75	75
Asystole	27	28
No Patient Involvement	14	14
Arrhythmia	10	10
Bradycardia	10	10
Cardiac Arrest	9	9
Tachycardia	9	9
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
Atrial Fibrillation	2	2
Discomfort	2	2
Shock	2	2
Undesired Nerve Stimulation	2	2
Loss of consciousness	2	2
Non specific EKG/ECG Changes	1	1
Syncope/Fainting	1	1
Pneumothorax	1	1
Pericardial Effusion	1	1
Cardiac Tamponade	1	1
Pleural Effusion	1	1
Fall	1	1
Pain	1	1