TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
BIOTRONIK, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	874	874
Computer Operating System Problem	777	777
Communication or Transmission Problem	607	607
Display or Visual Feedback Problem	568	568
Output Problem	149	149
Data Problem	117	117
Capturing Problem	115	115
Device Difficult to Program or Calibrate	112	112
Failure to Interrogate	107	107
Pacing Problem	85	85
Device Sensing Problem	74	74
Inadequate User Interface	46	46
Application Program Problem	23	23
Device Displays Incorrect Message	20	20
Failure to Capture	20	20
Power Problem	18	18
Impedance Problem	16	16
Signal Artifact/Noise	13	13
Over-Sensing	12	12
Inappropriate/Inadequate Shock/Stimulation	10	10
Unexpected Shutdown	10	10
Problem with Software Installation	8	8
Mechanical Problem	7	7
Under-Sensing	6	6
High impedance	5	5
Appropriate Term/Code Not Available	4	4
Connection Problem	4	4
Loose or Intermittent Connection	4	4
Unable to Obtain Readings	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Battery Problem	2	2
Failure to Power Up	2	2
Application Interface Becomes Non-Functional Or Program Exits Abnormally	2	2
Wireless Communication Problem	2	2
Application Program Version or Upgrade Problem	2	2
Reset Problem	2	2
High Capture Threshold	2	2
Program or Algorithm Execution Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Integrity Problem	1	1
Failure to Sense	1	1
Image Display Error/Artifact	1	1
Device Operational Issue	1	1
Low impedance	1	1
Corroded	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1999	1999
No Known Impact Or Consequence To Patient	225	225
No Consequences Or Impact To Patient	76	76
Asystole	24	24
No Patient Involvement	15	15
Cardiac Arrest	9	9
Arrhythmia	6	6
Shock from Patient Lead(s)	6	6
Bradycardia	5	5
Tachycardia	5	5
Low Blood Pressure/ Hypotension	4	4
Insufficient Information	3	3
Dizziness	2	2
Undesired Nerve Stimulation	2	2
Shock	2	2
Loss of consciousness	2	2
Heart Block	2	2
Non specific EKG/ECG Changes	1	1
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