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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable pulse generator, pacemaker (non-crt)
Definition These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Product CodeLWP
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
78 66 91 123 116 126 97 97 116 97 88 90 70 65 54 10

MDR Year MDR Reports MDR Events
2014 9399 9399
2015 9422 9422
2016 12356 12356
2017 11643 11643
2018 14937 14937
2019 9627 9627
2020 8989 8989
2021 9374 9374
2022 14287 14287
2023 12639 12639
2024 2700 2700

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 24729 24729
Premature Discharge of Battery 23908 23908
Device Displays Incorrect Message 12046 12046
High impedance 11444 11444
Over-Sensing 9330 9330
Pacing Problem 6350 6350
Failure to Capture 5937 5937
Pacemaker Found in Back-Up Mode 4515 4515
Device Operates Differently Than Expected 4289 4289
Battery Problem 4018 4018
Defective Device 3821 3821
Ambient Noise Problem 3186 3186
Device Dislodged or Dislocated 3165 3165
Device Sensing Problem 2939 2939
Signal Artifact/Noise 2874 2874
Incorrect, Inadequate or Imprecise Result or Readings 2733 2733
High Capture Threshold 2723 2723
Capturing Problem 2642 2642
Low impedance 2549 2549
Material Integrity Problem 2546 2546
Device Alarm System 2005 2005
Connection Problem 1967 1967
Under-Sensing 1890 1890
Failure to Interrogate 1867 1867
Appropriate Term/Code Not Available 1827 1827
Nonstandard Device 1710 1710
Mechanical Problem 1318 1318
Noise, Audible 1265 1265
Inappropriate/Inadequate Shock/Stimulation 1152 1152
Impedance Problem 1112 1112
Output Problem 833 833
Communication or Transmission Problem 767 767
Inappropriate or Unexpected Reset 753 753
Electrical /Electronic Property Problem 751 751
No Display/Image 727 727
No Device Output 711 711
Incorrect Measurement 697 697
Pocket Stimulation 692 692
No Pacing 663 663
Use of Device Problem 627 627
Data Problem 596 596
Telemetry Discrepancy 585 585
Interrogation Problem 529 529
Fracture 520 520
Break 437 437
Failure to Read Input Signal 432 432
Human-Device Interface Problem 424 424
Insufficient Information 401 401
Power Problem 388 388
Positioning Problem 381 381
No Apparent Adverse Event 361 361
Premature Elective Replacement Indicator 332 332
Operating System Version or Upgrade Problem 318 318
Loose or Intermittent Connection 314 314
Difficult to Remove 304 304
Difficult To Position 301 301
Reset Problem 299 299
Failure to Sense 266 266
Defibrillation/Stimulation Problem 257 257
Difficult to Insert 253 253
Migration or Expulsion of Device 252 252
Off-Label Use 247 247
Migration 229 229
Failure of Device to Self-Test 192 192
Device Contamination with Chemical or Other Material 188 188
Fitting Problem 175 175
Inaccurate Synchronization 171 171
Unexpected Therapeutic Results 168 168
Intermittent Capture 168 168
Wireless Communication Problem 165 165
Programming Issue 159 159
Failure to Convert Rhythm 158 158
Pacing Asynchronously 154 154
Misconnection 146 146
Calibration Problem 131 131
Failure to Power Up 128 128
Failure to Disconnect 120 120
Unexpected Shutdown 120 120
Contamination 109 109
Unable to Obtain Readings 107 107
Patient-Device Incompatibility 106 106
Unstable Capture Threshold 100 100
Crack 92 92
False Positive Result 91 91
Pacing Inadequately 91 91
Display or Visual Feedback Problem 89 89
Difficult to Interrogate 87 87
Component Missing 84 84
Pacing Intermittently 83 83
No Audible Alarm 81 81
Sensing Intermittently 79 79
Device Contamination With Biological Material 72 72
Improper Alarm 71 71
Delayed Charge Time 71 71
Missing Test Results 68 68
Loss of Data 61 61
Improper Device Output 60 60
Battery Problem: High Impedance 58 58
Contamination /Decontamination Problem 58 58
Protective Measures Problem 56 56

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 34794 34794
No Clinical Signs, Symptoms or Conditions 29009 29009
No Consequences Or Impact To Patient 17827 17827
Unspecified Infection 13578 13578
No Code Available 4683 4683
No Patient Involvement 3528 3528
Sepsis 3055 3055
Insufficient Information 2404 2404
Syncope 2011 2011
Pocket Erosion 1643 1643
Dizziness 1246 1246
Death 1227 1227
Complaint, Ill-Defined 1125 1126
Muscle Stimulation 1111 1111
Bradycardia 760 760
Syncope/Fainting 743 743
Cardiac Arrest 735 735
Arrhythmia 706 706
Atrial Fibrillation 633 633
Discomfort 624 624
Electric Shock 554 554
Erosion 535 535
Dyspnea 527 527
Fatigue 511 511
Pain 476 477
Asystole 462 462
No Information 458 458
Bacterial Infection 427 427
Endocarditis 401 401
Fall 392 392
Device Overstimulation of Tissue 391 391
Hematoma 374 374
Ventricular Tachycardia 354 354
Cardiac Perforation 313 313
Staphylococcus Aureus 292 292
Ventricular Fibrillation 265 265
Undesired Nerve Stimulation 256 256
Chest Pain 255 255
Palpitations 204 204
Twiddlers Syndrome 178 178
Wound Dehiscence 177 177
Pericardial Effusion 172 172
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 161 161
Fever 159 159
Heart Failure 156 156
Tachycardia 139 139
Swelling 126 126
Complete Heart Block 118 118
Purulent Discharge 113 113
Atrial Flutter 109 109
Low Blood Pressure/ Hypotension 107 107
Patient Problem/Medical Problem 98 98
Anxiety 94 94
Inflammation 90 90
Unspecified Heart Problem 87 87
Presyncope 80 80
Swelling/ Edema 73 73
Loss of consciousness 70 70
Hypersensitivity/Allergic reaction 68 68
Atrial Tachycardia 62 62
Weakness 59 59
Cardiac Tamponade 57 57
Fainting 56 56
Non specific EKG/ECG Changes 54 54
Vascular Dissection 54 54
Pneumothorax 51 51
Nausea 48 48
Congestive Heart Failure 48 48
Twitching 47 47
Post Operative Wound Infection 46 46
Malaise 46 46
Atrial Perforation 45 45
Stroke/CVA 45 45
Head Injury 44 44
Perforation 43 43
Fluid Discharge 43 43
Shock from Patient Lead(s) 42 42
Heart Failure/Congestive Heart Failure 42 42
Hemorrhage/Bleeding 42 42
High Blood Pressure/ Hypertension 40 40
Twiddlers Syndrome 40 40
Cardiopulmonary Arrest 38 38
Burning Sensation 37 37
Cardiomyopathy 36 36
Respiratory Failure 35 35
Exit Block 34 34
Occlusion 34 34
Seizures 33 33
Cancer 33 33
Impaired Healing 32 32
Discharge 32 32
Pleural Effusion 31 31
Pneumonia 30 30
Septic Shock 30 30
Thrombosis 29 29
Perforation of Vessels 29 29
Abscess 28 28
Myocardial Infarction 27 27
Failure of Implant 26 26
Renal Failure 24 24

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific CRM Corp II Oct-18-2014
2 Boston Scientific CRM Corp II Oct-17-2013
3 Boston Scientific CRM Corp II Oct-07-2010
4 Boston Scientific CRM Corp II May-08-2010
5 Boston Scientific CRM Corp II Jan-13-2010
6 Boston Scientific CRM Corp II Aug-18-2009
7 Boston Scientific CRM Corp II Jul-17-2009
8 Boston Scientific CRM Corp II Jul-14-2009
9 Boston Scientific Corporation I Jul-13-2021
10 Boston Scientific Corporation II Jul-02-2021
11 Boston Scientific Corporation II Jan-15-2018
12 Boston Scientific Corporation II Dec-30-2016
13 Boston Scientific Corporation II Sep-07-2016
14 Medtronic Inc. Cardiac Rhythm Disease Management II May-24-2014
15 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-22-2010
16 St Jude Medical Inc. II Jun-12-2018
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