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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)
2019 2020 2021 2022 2023 2024
88 90 70 65 54 10

MDR Year MDR Reports MDR Events
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 15467 15467
Premature Discharge of Battery 15377 15377
Over-Sensing 4569 4569
High impedance 4184 4184
Battery Problem 3833 3833
Defective Device 3481 3481
Device Displays Incorrect Message 3246 3246
Pacing Problem 2983 2983
Incorrect, Inadequate or Imprecise Result or Readings 2706 2706
Signal Artifact/Noise 2623 2623
Failure to Capture 2272 2272
High Capture Threshold 1767 1767
Under-Sensing 1157 1157
Noise, Audible 1147 1147
Failure to Interrogate 1146 1146
Pacemaker Found in Back-Up Mode 941 941
Device Sensing Problem 891 891
Device Dislodged or Dislocated 833 833
Low impedance 789 789
Connection Problem 597 597
Inappropriate/Inadequate Shock/Stimulation 585 585
No Pacing 577 577
Incorrect Measurement 567 567
Material Integrity Problem 555 555
Interrogation Problem 513 513
Failure to Read Input Signal 426 426
Impedance Problem 418 418
Data Problem 416 416
No Apparent Adverse Event 349 349
Inappropriate or Unexpected Reset 261 261
Pocket Stimulation 257 257
Telemetry Discrepancy 256 256
Off-Label Use 236 236
Loose or Intermittent Connection 231 231
Migration 219 219
Insufficient Information 197 197
Use of Device Problem 189 189
Appropriate Term/Code Not Available 169 169
Capturing Problem 166 166
Difficult to Insert 166 166
Inaccurate Synchronization 165 165
Positioning Problem 154 154
Output Problem 153 153
Unexpected Therapeutic Results 153 153
Pacing Asynchronously 152 152
Mechanical Problem 139 139
Communication or Transmission Problem 129 129
Reset Problem 120 120
Break 116 116
No Display/Image 115 115
Difficult to Remove 114 114
Wireless Communication Problem 113 113
Failure to Disconnect 111 111
Misconnection 104 104
Fracture 103 103
Patient-Device Incompatibility 98 98
Failure to Sense 98 98
Unexpected Shutdown 97 97
No Device Output 94 94
False Positive Result 91 91
Display or Visual Feedback Problem 76 76
Failure to Convert Rhythm 74 74
Delayed Charge Time 70 70
Calibration Problem 67 67
Device Alarm System 67 67
Intermittent Capture 64 64
Migration or Expulsion of Device 63 63
Electrical /Electronic Property Problem 55 55
Premature Elective Replacement Indicator 51 51
Unable to Obtain Readings 48 48
Unstable Capture Threshold 42 42
Therapy Delivered to Incorrect Body Area 41 41
Pacing Intermittently 40 40
Failure to Select Signal 40 40
Unintended Electrical Shock 38 38
Therapeutic or Diagnostic Output Failure 35 35
Human-Device Interface Problem 35 35
Packaging Problem 33 33
Loss of Data 31 31
Pacing Inadequately 31 31
Missing Test Results 29 29
No Audible Alarm 28 28
Electromagnetic Interference 26 26
Defibrillation/Stimulation Problem 26 26
Program or Algorithm Execution Problem 26 26
Battery Problem: High Impedance 25 25
Contamination of Device Ingredient or Reagent 23 23
Failure to Power Up 22 22
Contamination /Decontamination Problem 21 21
Device Markings/Labelling Problem 21 21
Separation Failure 18 18
Material Discolored 17 17
Sensing Intermittently 16 16
Fitting Problem 16 16
Inadequate User Interface 16 16
Power Problem 15 15
Detachment of Device or Device Component 15 15
Failure to Charge 14 14
Device Difficult to Program or Calibrate 14 14
Device Contamination with Chemical or Other Material 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28871 28871
No Known Impact Or Consequence To Patient 9128 9128
Unspecified Infection 7042 7042
No Code Available 4384 4384
No Consequences Or Impact To Patient 3344 3344
Insufficient Information 2372 2372
Sepsis 1537 1537
Pocket Erosion 984 984
Syncope/Fainting 738 738
Arrhythmia 544 544
Dizziness 530 530
Electric Shock 530 530
Discomfort 481 481
Asystole 462 462
No Patient Involvement 423 423
Device Overstimulation of Tissue 376 376
Bradycardia 372 372
Syncope 362 362
Bacterial Infection 295 295
Dyspnea 223 223
Muscle Stimulation 216 216
Death 210 210
No Information 198 198
Pain 196 196
Fatigue 195 195
Atrial Fibrillation 186 186
Erosion 184 184
Hematoma 184 184
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 160 160
Wound Dehiscence 135 135
Endocarditis 133 133
Fall 125 125
Cardiac Arrest 100 100
Ventricular Fibrillation 91 91
Chest Pain 89 89
Unspecified Heart Problem 87 87
Undesired Nerve Stimulation 86 86
Presyncope 79 79
Anxiety 77 77
Swelling/ Edema 73 73
Tachycardia 68 68
Fever 68 68
Staphylococcus Aureus 60 60
Purulent Discharge 57 57
Loss of consciousness 56 56
Twiddlers Syndrome 48 48
Hypersensitivity/Allergic reaction 47 47
Low Blood Pressure/ Hypotension 44 44
Ventricular Tachycardia 43 43
Palpitations 43 43
Fluid Discharge 42 42
Heart Failure/Congestive Heart Failure 42 42
Twiddlers Syndrome 40 40
Malaise 40 40
Pericardial Effusion 36 36
Shock from Patient Lead(s) 33 33
Complaint, Ill-Defined 33 33
Non specific EKG/ECG Changes 31 31
Impaired Healing 31 31
Cardiac Perforation 28 28
Swelling 28 28
Perforation 27 27
Inflammation 26 26
Head Injury 26 26
Atrial Flutter 25 25
Muscle Weakness 23 23
Heart Block 22 22
Pneumothorax 21 21
Heart Failure 21 21
Failure of Implant 20 20
Implant Pain 20 20
Vascular Dissection 19 19
Cardiac Tamponade 19 19
Nausea 18 18
Hemorrhage/Bleeding 18 18
Complete Heart Block 18 18
Burning Sensation 17 17
Weakness 16 16
Abscess 16 16
Obstruction/Occlusion 16 16
Foreign Body In Patient 15 15
Stroke/CVA 15 15
Itching Sensation 15 15
High Blood Pressure/ Hypertension 14 14
Twitching 14 14
Rash 13 13
Septic Shock 13 13
Erythema 13 13
Cardiomyopathy 13 13
Thrombosis/Thrombus 12 12
Convulsion/Seizure 11 11
Seizures 11 11
Occlusion 10 10
Atrial Tachycardia 10 10
Headache 10 10
Pleural Effusion 9 9
Injury 9 9
Bone Fracture(s) 8 8
Cellulitis 8 8
Bruise/Contusion 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jul-13-2021
2 Boston Scientific Corporation II Jul-02-2021
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