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	730	730
Computer Operating System Problem	661	661
Display or Visual Feedback Problem	471	471
Communication or Transmission Problem	465	465
Capturing Problem	112	112
Data Problem	108	108
Device Difficult to Program or Calibrate	106	106
Output Problem	101	101
Failure to Interrogate	97	97
Pacing Problem	73	73
Device Sensing Problem	68	68
Inadequate User Interface	44	44
Failure to Capture	19	19
Device Displays Incorrect Message	18	18
Power Problem	17	17
Impedance Problem	14	14
Signal Artifact/Noise	13	13
Over-Sensing	12	12
Application Program Problem	11	11
Unexpected Shutdown	10	10
Inappropriate/Inadequate Shock/Stimulation	8	8
Problem with Software Installation	7	7
Mechanical Problem	6	6
High impedance	5	5
Under-Sensing	5	5
Connection Problem	4	4
Loose or Intermittent Connection	4	4
Appropriate Term/Code Not Available	4	4
Unable to Obtain Readings	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Application Interface Becomes Non-Functional Or Program Exits Abnormally	2	2
Failure to Power Up	2	2
Reset Problem	2	2
Battery Problem	2	2
Wireless Communication Problem	2	2
Program or Algorithm Execution Problem	1	1
Material Integrity Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
High Capture Threshold	1	1
Noise, Audible	1	1
Low impedance	1	1
Application Program Version or Upgrade Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Operational Issue	1	1
Failure to Sense	1	1
Image Display Error/Artifact	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1669	1669
No Known Impact Or Consequence To Patient	225	225
No Consequences Or Impact To Patient	76	76
Asystole	19	19
No Patient Involvement	15	15
Cardiac Arrest	8	8
Arrhythmia	5	5
Shock from Patient Lead(s)	5	5
Bradycardia	4	4
Tachycardia	3	3
Insufficient Information	3	3
Heart Block	2	2
Dizziness	2	2
Shock	2	2
Loss of consciousness	2	2
Low Blood Pressure/ Hypotension	2	2
Undesired Nerve Stimulation	1	1
Pleural Effusion	1	1
Pneumothorax	1	1
Atrial Fibrillation	1	1
Non specific EKG/ECG Changes	1	1
Fall	1	1
Cardiac Tamponade	1	1
Pericardial Effusion	1	1
Syncope/Fainting	1	1