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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)
2018 2019 2020 2021 2022 2023
97 88 90 70 65 37

MDR Year MDR Reports MDR Events
2018 14935 14935
2019 9627 9627
2020 8989 8989
2021 9374 9374
2022 14287 14287
2023 8876 8876

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17153 17153
Premature Discharge of Battery 16836 16836
Device Displays Incorrect Message 5787 5787
High impedance 5705 5705
Over-Sensing 5018 5018
Battery Problem 3440 3440
Defective Device 3354 3354
Pacing Problem 3354 3354
Failure to Capture 2945 2945
Signal Artifact/Noise 2236 2236
Incorrect, Inadequate or Imprecise Result or Readings 1842 1842
Device Dislodged or Dislocated 1837 1837
Material Integrity Problem 1713 1713
High Capture Threshold 1598 1598
Pacemaker Found in Back-Up Mode 1578 1578
Device Sensing Problem 1337 1337
Ambient Noise Problem 1298 1298
Capturing Problem 1295 1295
Noise, Audible 1211 1211
Failure to Interrogate 1073 1073
Low impedance 1046 1046
Under-Sensing 999 999
Connection Problem 776 776
Inappropriate/Inadequate Shock/Stimulation 632 632
Device Operates Differently Than Expected 590 590
Impedance Problem 553 553
Incorrect Measurement 540 540
No Pacing 496 496
Data Problem 472 472
Device Alarm System 471 471
Interrogation Problem 430 430
Pocket Stimulation 408 408
Inappropriate or Unexpected Reset 355 355
Communication or Transmission Problem 329 329
Human-Device Interface Problem 299 299
Fracture 281 281
No Apparent Adverse Event 273 273
Failure to Read Input Signal 272 272
Use of Device Problem 262 262
Appropriate Term/Code Not Available 233 233
Telemetry Discrepancy 227 227
Off-Label Use 216 216
Migration 212 212
Output Problem 212 212
Loose or Intermittent Connection 211 211
Mechanical Problem 210 210
Positioning Problem 208 208
Insufficient Information 176 176
Difficult to Remove 170 170
Difficult to Insert 162 162
Electrical /Electronic Property Problem 161 161
Difficult To Position 158 158
Reset Problem 155 155
Break 152 152
Unexpected Therapeutic Results 147 147
Inaccurate Synchronization 145 145
No Display/Image 141 141
Misconnection 139 139
Operating System Version or Upgrade Problem 137 137
No Device Output 130 130
Failure to Sense 126 126
Wireless Communication Problem 119 119
Unexpected Shutdown 118 118
Pacing Asynchronously 117 117
Migration or Expulsion of Device 110 110
Patient-Device Incompatibility 105 105
Premature Elective Replacement Indicator 101 101
Failure to Convert Rhythm 94 94
Failure to Disconnect 90 90
False Positive Result 85 85
Display or Visual Feedback Problem 79 79
Intermittent Capture 74 74
Calibration Problem 73 73
Defibrillation/Stimulation Problem 64 64
Delayed Charge Time 59 59
Unable to Obtain Readings 58 58
Fitting Problem 51 51
Failure to Select Signal 49 49
Unstable Capture Threshold 46 46
Pacing Intermittently 42 42
Pacing Inadequately 40 40
Missing Test Results 39 39
Unintended Electrical Shock 38 38
Contamination /Decontamination Problem 37 37
Loss of Data 36 36
Battery Problem: High Impedance 36 36
Power Problem 36 36
Packaging Problem 36 36
Therapeutic or Diagnostic Output Failure 36 36
No Audible Alarm 35 35
Therapy Delivered to Incorrect Body Area 32 32
Failure to Power Up 29 29
Device Contamination With Biological Material 29 29
Electromagnetic Interference 27 27
Separation Failure 25 25
Contamination of Device Ingredient or Reagent 24 24
Program or Algorithm Execution Problem 23 23
Difficult to Interrogate 23 23
Nonstandard Device 22 22
Device Markings/Labelling Problem 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24367 24367
No Known Impact Or Consequence To Patient 15552 15552
Unspecified Infection 8563 8563
No Consequences Or Impact To Patient 7038 7038
No Code Available 4431 4431
Sepsis 2287 2287
Insufficient Information 2153 2153
Pocket Erosion 1119 1119
Syncope 827 827
No Patient Involvement 730 730
Dizziness 619 619
Syncope/Fainting 575 575
Arrhythmia 472 472
Muscle Stimulation 471 471
Electric Shock 471 471
Discomfort 426 426
Death 422 422
Bradycardia 419 419
Asystole 343 343
Complaint, Ill-Defined 318 318
Bacterial Infection 310 310
No Information 304 304
Device Overstimulation of Tissue 287 287
Atrial Fibrillation 283 283
Erosion 269 269
Pain 263 263
Dyspnea 255 255
Fatigue 225 225
Cardiac Perforation 225 225
Hematoma 209 209
Endocarditis 193 193
Fall 190 190
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 153 153
Cardiac Arrest 147 147
Chest Pain 144 144
Wound Dehiscence 129 129
Ventricular Fibrillation 123 123
Staphylococcus Aureus 120 120
Twiddlers Syndrome 106 106
Pericardial Effusion 106 106
Undesired Nerve Stimulation 104 104
Fever 100 100
Ventricular Tachycardia 95 95
Palpitations 84 84
Tachycardia 74 74
Anxiety 73 73
Purulent Discharge 71 71
Swelling 68 68
Low Blood Pressure/ Hypotension 64 64
Complete Heart Block 57 57
Unspecified Heart Problem 55 55
Presyncope 54 54
Swelling/ Edema 53 53
Inflammation 53 53
Heart Failure 48 48
Hypersensitivity/Allergic reaction 45 45
Non specific EKG/ECG Changes 44 44
Loss of consciousness 41 41
Atrial Flutter 38 38
Twiddlers Syndrome 36 36
Fluid Discharge 33 33
Atrial Perforation 33 33
Malaise 32 32
Head Injury 31 31
Weakness 29 29
Nausea 28 28
Perforation 28 28
Cardiac Tamponade 28 28
Patient Problem/Medical Problem 28 28
Hemorrhage/Bleeding 27 27
Pneumothorax 26 26
Vascular Dissection 26 26
Heart Failure/Congestive Heart Failure 26 26
Discharge 23 23
Abscess 22 22
Stroke/CVA 22 22
Cardiomyopathy 19 19
Heart Block 19 19
Impaired Healing 18 18
High Blood Pressure/ Hypertension 18 18
Seizures 18 18
Muscle Weakness 18 18
Failure of Implant 17 17
Pleural Effusion 17 17
Septic Shock 17 17
Occlusion 17 17
Thrombosis 17 17
Burning Sensation 16 16
Cardiopulmonary Arrest 16 16
Post Operative Wound Infection 16 16
Obstruction/Occlusion 15 15
Atrial Tachycardia 15 15
Fainting 15 15
Myocardial Infarction 15 15
Headache 14 14
Bone Fracture(s) 14 14
Foreign Body In Patient 14 14
Implant Pain 13 13
Congestive Heart Failure 13 13
Itching Sensation 13 13

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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