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	699	699
Computer Operating System Problem	607	607
Display or Visual Feedback Problem	458	458
Communication or Transmission Problem	431	431
Capturing Problem	112	112
Device Difficult to Program or Calibrate	104	104
Data Problem	104	104
Failure to Interrogate	94	94
Output Problem	92	92
Pacing Problem	72	72
Device Sensing Problem	68	68
Inadequate User Interface	43	43
Failure to Capture	19	19
Power Problem	17	17
Device Displays Incorrect Message	17	17
Impedance Problem	14	14
Signal Artifact/Noise	13	13
Over-Sensing	12	12
Application Program Problem	10	10
Unexpected Shutdown	10	10
Inappropriate/Inadequate Shock/Stimulation	7	7
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
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 Power Up	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	1564	1564
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
Bradycardia	4	4
Shock from Patient Lead(s)	4	4
Tachycardia	3	3
Insufficient Information	3	3
Loss of consciousness	2	2
Heart Block	2	2
Dizziness	2	2
Shock	2	2
Low Blood Pressure/ Hypotension	2	2
Undesired Nerve Stimulation	1	1
Pleural Effusion	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