TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
MEDTRONIC, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	7
OSYPKA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Connection Problem	2484	2484
Mechanical Problem	1013	1013
No Display/Image	762	762
Calibration Problem	522	522
Display or Visual Feedback Problem	469	469
Output Problem	434	434
Break	360	360
Failure to Power Up	306	306
Device Sensing Problem	276	276
No Device Output	261	261
Device Displays Incorrect Message	244	244
Use of Device Problem	223	223
Unexpected Shutdown	218	218
Nonstandard Device	204	204
Electrical /Electronic Property Problem	186	186
Component Missing	186	186
Material Integrity Problem	172	172
Corroded	138	138
Battery Problem	105	105
Contamination	102	102
Power Problem	98	98
Failure to Capture	90	90
Loose or Intermittent Connection	85	85
Crack	64	64
Device Operates Differently Than Expected	63	63
Capturing Problem	54	54
Failure to Sense	52	52
Under-Sensing	44	44
Pacing Problem	37	37
Pacing Intermittently	36	36
Moisture Damage	35	35
Insufficient Information	33	33
Computer Software Problem	31	31
Inadequate User Interface	25	25
Device Difficult to Program or Calibrate	23	23
Intermittent Capture	20	20
Failure of Device to Self-Test	18	18
Adverse Event Without Identified Device or Use Problem	18	18
Device Contamination with Chemical or Other Material	17	17
Degraded	16	16
Failure to Shut Off	16	16
Output below Specifications	16	16
Over-Sensing	15	15
Operating System Becomes Nonfunctional	14	14
Blocked Connection	13	13
Contamination /Decontamination Problem	13	13
Difficult to Insert	13	13
Output above Specifications	12	12
Signal Artifact/Noise	10	10
Data Problem	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	3169	3169
No Clinical Signs, Symptoms or Conditions	2937	2937
No Known Impact Or Consequence To Patient	1095	1095
No Consequences Or Impact To Patient	103	103
Cardiac Arrest	74	74
Ventricular Fibrillation	39	39
Arrhythmia	30	30
Tachycardia	23	23
Bradycardia	21	21
Ventricular Tachycardia	20	20
Asystole	16	16
R On T Phenomenon	11	11
Loss of consciousness	11	11
Death	8	8
No Information	7	7
Heart Block	5	5
No Code Available	5	5
Complete Heart Block	5	5
Superficial (First Degree) Burn	4	4
Low Blood Pressure/ Hypotension	4	4
Low Oxygen Saturation	3	3
Cardiopulmonary Arrest	3	3
Insufficient Information	3	3
Erythema	3	3
Chest Pain	3	3
Injury	3	3
Non specific EKG/ECG Changes	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Abrasion	2	2
Burn, Thermal	2	2
Pericardial Effusion	2	2
Blister	2	2
Electro-Mechanical Dissociation	2	2
Syncope	2	2
Loss Of Pulse	2	2
Skin Inflammation/ Irritation	2	2
Cardiogenic Shock	2	2
Hypoxia	2	2
Sudden Cardiac Death	2	2
Diaphoresis	2	2
Shock	2	2
Seizures	2	2
Pneumonia	2	2
Bruise/Contusion	1	1
Respiratory Failure	1	1
Atrial Flutter	1	1
Hemorrhage/Bleeding	1	1
Headache	1	1
Ventricular Flutter	1	1
Syncope/Fainting	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bio-Detek, Inc.	II	Jul-03-2019
2	Medtronic Inc. Cardiac Rhythm Disease Management	II	Mar-31-2015
3	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Jun-29-2018
4	Osypka Medical Inc	II	Sep-21-2010