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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)
2017 2018 2019 2020 2021 2022
116 97 88 90 70 53

MDR Year MDR Reports MDR Events
2017 11644 11644
2018 14936 14936
2019 9629 9629
2020 8988 8988
2021 9378 9378
2022 10921 10921

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 17107 17107
Adverse Event Without Identified Device or Use Problem 14182 14182
Device Displays Incorrect Message 7884 7884
High impedance 6492 6492
Over-Sensing 5093 5093
Pacing Problem 3398 3398
Failure to Capture 3246 3246
Battery Problem 2599 2599
Defective Device 2547 2547
Material Integrity Problem 2217 2217
Ambient Noise Problem 2213 2213
Pacemaker Found in Back-Up Mode 2167 2167
Device Dislodged or Dislocated 2126 2126
Capturing Problem 1863 1863
Signal Artifact/Noise 1647 1647
Device Operates Differently Than Expected 1565 1565
Device Sensing Problem 1517 1517
High Capture Threshold 1380 1380
Noise, Audible 1171 1171
Low impedance 1161 1161
Incorrect, Inadequate or Imprecise Result or Readings 1006 1006
Connection Problem 954 954
Device Alarm System 936 936
Failure to Interrogate 858 858
Under-Sensing 837 837
Inappropriate/Inadequate Shock/Stimulation 643 643
Impedance Problem 603 603
Pocket Stimulation 515 515
Incorrect Measurement 481 481
Inappropriate or Unexpected Reset 462 462
Data Problem 451 451
Communication or Transmission Problem 438 438
Human-Device Interface Problem 396 396
Fracture 365 365
Use of Device Problem 363 363
No Pacing 353 353
Operating System Version or Upgrade Problem 316 316
Interrogation Problem 299 299
Mechanical Problem 290 290
Electrical /Electronic Property Problem 281 281
Telemetry Discrepancy 279 279
Difficult To Position 276 276
Output Problem 259 259
Appropriate Term/Code Not Available 257 257
No Display/Image 210 210
No Device Output 209 209
Positioning Problem 199 199
No Apparent Adverse Event 192 192
Difficult to Remove 190 190
Off-Label Use 184 184
Reset Problem 180 180
Migration 177 177
Break 177 177
Loose or Intermittent Connection 171 171
Difficult to Insert 159 159
Premature Elective Replacement Indicator 154 154
Migration or Expulsion of Device 148 148
Misconnection 137 137
Failure to Sense 137 137
Unexpected Therapeutic Results 131 131
Inaccurate Synchronization 112 112
Failure to Read Input Signal 110 110
Wireless Communication Problem 109 109
Defibrillation/Stimulation Problem 107 107
Failure to Convert Rhythm 103 103
Patient-Device Incompatibility 102 102
Unexpected Shutdown 101 101
Fitting Problem 93 93
Insufficient Information 89 89
Pacing Asynchronously 83 83
Device Contamination with Chemical or Other Material 82 82
Calibration Problem 74 74
Power Problem 72 72
Display or Visual Feedback Problem 71 71
Failure to Disconnect 70 70
Intermittent Capture 68 68
False Positive Result 68 68
Device Contamination With Biological Material 61 61
Unable to Obtain Readings 59 59
Pacing Inadequately 58 58
Programming Issue 50 50
Failure to Select Signal 49 49
Pacing Intermittently 48 48
Unstable Capture Threshold 45 45
Missing Test Results 45 45
Delayed Charge Time 44 44
Difficult to Interrogate 42 42
No Audible Alarm 42 42
Unintended Electrical Shock 38 38
Contamination /Decontamination Problem 38 38
Loss of Data 38 38
Failure to Power Up 37 37
Battery Problem: High Impedance 36 36
Electromagnetic Interference 29 29
Inadequate User Interface 28 28
Contamination 27 27
Premature End-of-Life Indicator 25 25
Separation Failure 25 25
Problem with Software Installation 25 25
Device Markings/Labelling Problem 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 21123 21123
No Clinical Signs, Symptoms or Conditions 14992 14992
No Consequences Or Impact To Patient 9761 9761
Unspecified Infection 8896 8896
No Code Available 4447 4447
Sepsis 2756 2756
Insufficient Information 1479 1479
Syncope 1177 1177
No Patient Involvement 1135 1135
Pocket Erosion 1060 1060
Death 706 706
Dizziness 686 686
Muscle Stimulation 683 683
Complaint, Ill-Defined 552 553
Bradycardia 429 429
No Information 409 409
Atrial Fibrillation 378 378
Arrhythmia 360 360
Electric Shock 357 357
Discomfort 355 355
Syncope/Fainting 341 341
Erosion 338 338
Cardiac Perforation 293 293
Dyspnea 289 289
Pain 286 286
Bacterial Infection 278 278
Fatigue 248 248
Hematoma 225 225
Endocarditis 224 224
Fall 204 204
Cardiac Arrest 199 199
Asystole 192 192
Device Overstimulation of Tissue 186 186
Staphylococcus Aureus 180 180
Chest Pain 167 167
Ventricular Fibrillation 166 166
Ventricular Tachycardia 165 165
Twiddlers Syndrome 135 135
Pericardial Effusion 132 132
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 126 126
Palpitations 126 126
Undesired Nerve Stimulation 117 117
Fever 107 107
Wound Dehiscence 104 104
Swelling 96 96
Complete Heart Block 84 84
Tachycardia 82 82
Heart Failure 81 81
Purulent Discharge 76 76
Anxiety 71 71
Low Blood Pressure/ Hypotension 70 70
Inflammation 64 64
Patient Problem/Medical Problem 58 58
Atrial Flutter 52 52
Non specific EKG/ECG Changes 49 49
Hypersensitivity/Allergic reaction 47 47
Atrial Perforation 42 42
Atrial Tachycardia 38 38
Weakness 38 38
Cardiac Tamponade 37 37
Post Operative Wound Infection 37 37
Presyncope 36 36
Swelling/ Edema 34 34
Fainting 34 34
Pneumothorax 33 33
Nausea 32 32
Unspecified Heart Problem 31 31
Vascular Dissection 30 30
Loss of consciousness 29 29
Discharge 29 29
Fluid Discharge 29 29
Hemorrhage/Bleeding 29 29
Head Injury 28 28
Cardiopulmonary Arrest 28 28
Occlusion 28 28
Pneumonia 25 25
Congestive Heart Failure 25 25
Malaise 25 25
Stroke/CVA 24 24
Seizures 24 24
Thrombosis 23 23
High Blood Pressure/ Hypertension 23 23
Abscess 22 22
Perforation of Vessels 22 22
Pleural Effusion 22 22
Cardiomyopathy 20 20
Exit Block 20 20
Twiddlers Syndrome 20 20
Perforation 19 19
Septic Shock 19 19
Heart Failure/Congestive Heart Failure 17 17
Myocardial Infarction 16 16
Burning Sensation 15 15
Bruise/Contusion 15 15
Bone Fracture(s) 15 15
Edema 15 15
Respiratory Failure 15 15
Injury 15 15
Lethargy 14 14
Necrosis 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jul-13-2021
2 Boston Scientific Corporation II Jul-02-2021
3 Boston Scientific Corporation II Jan-15-2018
4 St Jude Medical Inc. II Jun-12-2018
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