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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 31

MDR Year MDR Reports MDR Events
2014 9400 9400
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 7069 7069

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25615 25615
Premature Discharge of Battery 24535 24535
Device Displays Incorrect Message 12046 12046
High impedance 11729 11729
Over-Sensing 9982 9982
Pacing Problem 6759 6759
Failure to Capture 6262 6262
Pacemaker Found in Back-Up Mode 4527 4527
Device Operates Differently Than Expected 4289 4289
Battery Problem 4262 4262
Defective Device 4177 4177
Incorrect, Inadequate or Imprecise Result or Readings 3385 3385
Signal Artifact/Noise 3260 3260
Device Dislodged or Dislocated 3222 3222
Ambient Noise Problem 3186 3186
Device Sensing Problem 2969 2969
High Capture Threshold 2922 2922
Capturing Problem 2663 2663
Low impedance 2619 2619
Material Integrity Problem 2579 2579
Under-Sensing 2137 2137
Failure to Interrogate 2041 2041
Connection Problem 2012 2012
Device Alarm System 2005 2005
Appropriate Term/Code Not Available 1834 1834
Nonstandard Device 1710 1710
Mechanical Problem 1322 1322
Noise, Audible 1271 1271
Inappropriate/Inadequate Shock/Stimulation 1210 1210
Impedance Problem 1149 1149
Output Problem 839 839
Communication or Transmission Problem 778 778
Inappropriate or Unexpected Reset 773 773
Electrical /Electronic Property Problem 752 752
Incorrect Measurement 735 735
No Display/Image 732 732
No Pacing 732 732
No Device Output 719 719
Pocket Stimulation 713 713
Use of Device Problem 640 640
Data Problem 633 633
Telemetry Discrepancy 624 624
Interrogation Problem 595 595
Fracture 532 532
Failure to Read Input Signal 530 530
Break 441 441
Human-Device Interface Problem 424 424
Insufficient Information 414 414
No Apparent Adverse Event 414 414
Positioning Problem 394 394

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 32009 32009
No Consequences Or Impact To Patient 17827 17827
Unspecified Infection 14167 14167
No Code Available 4683 4683
No Patient Involvement 3528 3528
Sepsis 3085 3085
Insufficient Information 2557 2557
Syncope 2011 2011
Pocket Erosion 1743 1743
Dizziness 1322 1322
Death 1227 1227
Complaint, Ill-Defined 1125 1126
Muscle Stimulation 1111 1111
Syncope/Fainting 852 852
Arrhythmia 811 811
Bradycardia 806 806
Cardiac Arrest 742 742
Discomfort 700 700
Atrial Fibrillation 638 638
Dyspnea 565 565
Electric Shock 560 560
Erosion 542 542
Asystole 542 542
Fatigue 540 540
Pain 498 499
Bacterial Infection 458 458
No Information 458 458
Device Overstimulation of Tissue 453 453
Endocarditis 409 409
Fall 408 408
Hematoma 387 387
Ventricular Tachycardia 354 354
Cardiac Perforation 314 314
Staphylococcus Aureus 292 292
Ventricular Fibrillation 273 273
Chest Pain 265 265
Undesired Nerve Stimulation 262 262
Palpitations 205 205
Wound Dehiscence 195 195
Twiddlers Syndrome 178 178
Pericardial Effusion 178 178
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 164 164
Fever 162 162
Heart Failure 156 156
Tachycardia 142 142
Swelling 126 126
Purulent Discharge 121 121
Complete Heart Block 118 118
Unspecified Heart Problem 111 111

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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