TPLC - Total Product Life Cycle

show TPLC since

Device	pulse-generator, pacemaker, external
Regulation Description	External pacemaker pulse generator.
Product Code	DTE
Regulation Number	870.3600
Device Class	2

Premarket Reviews
Manufacturer	Decision
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLO PACE, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	629	629
Connection Problem	619	619
Mechanical Problem	601	601
Calibration Problem	392	392
Display or Visual Feedback Problem	353	353
Output Problem	350	350
Device Sensing Problem	244	244
No Device Output	221	221
Unexpected Shutdown	220	220
Use of Device Problem	208	208
Failure to Power Up	199	199
Break	170	171
Material Integrity Problem	137	137
Corroded	114	114
Battery Problem	104	104
Component Missing	87	87
Electrical /Electronic Property Problem	80	80
Contamination	80	80
Failure to Capture	69	69
Crack	58	58
Loose or Intermittent Connection	44	44
Capturing Problem	35	35
Power Problem	33	33
Under-Sensing	26	26
Pacing Problem	23	23
Pacing Intermittently	20	20
Output below Specifications	18	18
Moisture Damage	16	16
Over-Sensing	16	16
Failure to Sense	14	14
Adverse Event Without Identified Device or Use Problem	14	15
Premature Discharge of Battery	13	13
Intermittent Capture	12	13
Output above Specifications	10	10
Failure to Shut Off	8	8
Failure to Calibrate	6	6
Sensing Intermittently	6	6
Failure of Device to Self-Test	6	6
Inadequate User Interface	5	5
Key or Button Unresponsive/not Working	4	4
Operating System Becomes Nonfunctional	4	4
Blocked Connection	4	4
Circuit Failure	4	4
Device Contamination with Chemical or Other Material	3	3
Impedance Problem	3	3
Contamination /Decontamination Problem	3	3
Device Difficult to Program or Calibrate	3	3
Insufficient Device Problem Information	3	3
No Pacing	3	3
Application Program Freezes or Fails to Launch	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3765	3766
Cardiac Arrest	40	40
Asystole	31	31
Ventricular Fibrillation	31	31
Arrhythmia	25	26
Tachycardia	17	17
Bradycardia	13	13
Insufficient Information	8	8
Heart Block	8	8
Loss of consciousness	7	7
Superficial (First Degree) Burn	6	6
Low Blood Pressure/ Hypotension	5	6
Atrial Flutter	4	4
Erythema	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	4
Hemodynamic instability	2	2
Dizziness	2	2
Abrasion	2	2
Syncope/Fainting	2	2
Pericardial Effusion	2	3
Discomfort	2	2
Aspiration/Inhalation	2	2
Unspecified Heart Problem	2	2
Non specific EKG/ECG Changes	2	2
Blister	2	2
Multiple Organ Dysfunction Syndrome	2	2
Skin Inflammation/ Irritation	2	2
Pneumonia	2	2
Diaphoresis	2	2
Low Oxygen Saturation	2	2
Angina	1	1
Perforation	1	2
Respiratory Arrest	1	1
Swelling/ Edema	1	1
Muscle Weakness/Atrophy	1	1
Unspecified Infection	1	1
Burn(s)	1	1
Respiratory Failure	1	1
Stenosis	1	1
Cardiac Tamponade	1	1
Nausea	1	1
Ectopic Heartbeat	1	1
Sepsis	1	1
Intraoperative Cardiac Valve Injury	1	1
Device Overstimulation of Tissue	1	1
Dyspnea	1	1
Cardiac Perforation	1	1
Shock from Patient Lead(s)	1	1
Shock	1	1
Bruise/Contusion	1	1