TPLC - Total Product Life Cycle

• Device: programmer, pacemaker
• Product Code: KRG
• Regulation Number: 870.3700
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	1	1	2	0	0	0	0	0	0	0	0	0

MDR Year	MDR Reports	MDR Events
2014	2541	2541
2015	3244	3244
2016	1886	1886
2017	1407	1407
2018	1326	1326
2019	1174	1174
2020	1689	1689
2021	1700	1700
2022	1359	1359
2023	1070	1070
2024	1024	1024

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Difficult to Program or Calibrate	3227	3227
No Display/Image	2767	2767
Computer Operating System Problem	1802	1802
Communication or Transmission Problem	1719	1719
Output Problem	1492	1492
Computer Software Problem	1421	1421
Electrical /Electronic Property Problem	1224	1224
Failure to Calibrate	1083	1083
Failure to Power Up	719	719
Display or Visual Feedback Problem	710	710
Device Operates Differently Than Expected	692	692
Mechanical Problem	692	692
Unexpected Shutdown	624	624
Power Problem	619	619
Connection Problem	587	587
Overheating of Device	544	544
Inadequate User Interface	520	520
Problem with Software Installation	423	423
Failure to Interrogate	368	368
Break	352	352
Loose or Intermittent Connection	328	328
Noise, Audible	304	304
Material Integrity Problem	297	297
Data Problem	289	289
Operating System Becomes Nonfunctional	279	279
Use of Device Problem	270	270
Signal Artifact/Noise	222	222
Device Sensing Problem	172	172
Incorrect Measurement	151	151
Crack	148	148
Degraded	146	146
Corroded	142	142
Application Program Freezes, Becomes Nonfunctional	131	131
Adverse Event Without Identified Device or Use Problem	130	130
Calibration Problem	121	121
Battery Problem	120	120
High impedance	117	117
Device Displays Incorrect Message	110	110
Application Interface Becomes Non-Functional Or Program Exits Abnormally	103	103
Insufficient Information	89	89
Over-Sensing	84	84
Impedance Problem	75	75
Device Emits Odor	69	69
Application Program Problem	67	67
No Device Output	67	67
Interrogation Problem	60	60
Inappropriate/Inadequate Shock/Stimulation	56	56
Contamination	56	56
Electrical Shorting	56	56
Component Missing	52	52

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	6469	6469
No Clinical Signs, Symptoms or Conditions	5473	5473
No Patient Involvement	5375	5375
No Consequences Or Impact To Patient	897	897
No Information	118	118
Insufficient Information	55	55
Unspecified Infection	35	35
Cardiac Arrest	30	30
Syncope	18	18
Electric Shock	17	17
No Code Available	16	16
Shock	15	15
Dizziness	14	14
Ventricular Tachycardia	12	12
Death	11	11
Complaint, Ill-Defined	8	8
Ventricular Fibrillation	7	7
Atrial Fibrillation	7	7
Asystole	6	6
Arrhythmia	6	6
Sepsis	6	6
Discomfort	5	5
Pocket Erosion	5	5
Shock from Patient Lead(s)	5	5
Tachycardia	4	4
Staphylococcus Aureus	4	4
Loss of consciousness	4	4
Not Applicable	4	4
Heart Failure	3	3
Seizures	3	3
Endocarditis	3	3
Injury	3	3
Syncope/Fainting	3	3
Cardiopulmonary Arrest	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Non specific EKG/ECG Changes	3	3
Fainting	2	2
Bacterial Infection	2	2
Anxiety	2	2
Fall	2	2
Hemorrhage/Bleeding	1	1
Erosion	1	1
Therapeutic Effects, Unexpected	1	1
Convulsion/Seizure	1	1
Heart Block	1	1
Blurred Vision	1	1
Headache	1	1
Atrial Tachycardia	1	1
Sudden Cardiac Death	1	2
Renal Failure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific CRM Corp	II	Oct-07-2010
2	Boston Scientific CRM Corp	II	May-08-2010
3	Sorin Group USA, Inc.	II	Nov-15-2016