• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 16

MDR Year MDR Reports MDR Events
2019 9627 9627
2020 8989 8989
2021 9374 9374
2022 14287 14287
2023 12639 12639
2024 3584 3584

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15637 15637
Premature Discharge of Battery 15506 15506
Over-Sensing 4714 4714
High impedance 4229 4229
Battery Problem 3882 3882
Defective Device 3540 3540
Device Displays Incorrect Message 3246 3246
Pacing Problem 3055 3055
Incorrect, Inadequate or Imprecise Result or Readings 2833 2833
Signal Artifact/Noise 2695 2695
Failure to Capture 2339 2339
High Capture Threshold 1809 1809
Under-Sensing 1207 1207
Failure to Interrogate 1185 1185
Noise, Audible 1148 1148
Pacemaker Found in Back-Up Mode 953 953
Device Sensing Problem 895 895
Device Dislodged or Dislocated 845 845
Low impedance 800 800
Connection Problem 607 607
No Pacing 597 597
Inappropriate/Inadequate Shock/Stimulation 591 591
Incorrect Measurement 579 579
Material Integrity Problem 558 558
Interrogation Problem 530 530
Failure to Read Input Signal 437 437
Impedance Problem 424 424
Data Problem 419 419
No Apparent Adverse Event 361 361
Telemetry Discrepancy 270 270
Inappropriate or Unexpected Reset 264 264
Pocket Stimulation 260 260
Off-Label Use 236 236
Loose or Intermittent Connection 234 234
Migration 222 222
Insufficient Information 201 201
Use of Device Problem 191 191
Appropriate Term/Code Not Available 171 171
Inaccurate Synchronization 169 169
Capturing Problem 169 169
Difficult to Insert 168 168
Pacing Asynchronously 160 160
Positioning Problem 156 156
Output Problem 154 154
Unexpected Therapeutic Results 153 153
Mechanical Problem 139 139
Communication or Transmission Problem 130 130
Reset Problem 120 120
Break 118 118
No Display/Image 116 116
Difficult to Remove 115 115
Wireless Communication Problem 114 114
Failure to Disconnect 113 113
Fracture 106 106
Misconnection 105 105
Failure to Sense 101 101
Patient-Device Incompatibility 98 98
Unexpected Shutdown 98 98
No Device Output 97 97
False Positive Result 92 92
Display or Visual Feedback Problem 77 77
Failure to Convert Rhythm 75 75
Delayed Charge Time 70 70
Calibration Problem 67 67
Device Alarm System 67 67
Intermittent Capture 65 65
Migration or Expulsion of Device 63 63
Electrical /Electronic Property Problem 56 56
Premature Elective Replacement Indicator 52 52
Unable to Obtain Readings 48 48
Therapy Delivered to Incorrect Body Area 43 43
Unstable Capture Threshold 42 42
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 25 25
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 29495 29495
No Known Impact Or Consequence To Patient 9128 9128
Unspecified Infection 7155 7155
No Code Available 4384 4384
No Consequences Or Impact To Patient 3344 3344
Insufficient Information 2398 2398
Sepsis 1543 1543
Pocket Erosion 1006 1006
Syncope/Fainting 758 758
Arrhythmia 564 564
Dizziness 543 543
Electric Shock 531 531
Discomfort 496 496
Asystole 478 478
No Patient Involvement 423 423
Device Overstimulation of Tissue 387 387
Bradycardia 380 380
Syncope 362 362
Bacterial Infection 303 303
Dyspnea 234 234
Muscle Stimulation 216 216
Death 210 210
Fatigue 200 200
Pain 198 198
No Information 198 198
Atrial Fibrillation 186 186
Erosion 185 185
Hematoma 184 184
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 161 161
Wound Dehiscence 140 140
Endocarditis 133 133
Fall 130 130
Cardiac Arrest 102 102
Unspecified Heart Problem 94 94
Chest Pain 92 92
Ventricular Fibrillation 92 92
Undesired Nerve Stimulation 87 87
Presyncope 80 80
Anxiety 80 80
Swelling/ Edema 75 75
Tachycardia 69 69
Fever 68 68
Staphylococcus Aureus 60 60
Purulent Discharge 59 59
Loss of consciousness 56 56
Twiddlers Syndrome 48 48
Hypersensitivity/Allergic reaction 47 47
Low Blood Pressure/ Hypotension 46 46
Ventricular Tachycardia 43 43
Palpitations 43 43
Heart Failure/Congestive Heart Failure 43 43
Malaise 42 42
Fluid Discharge 42 42
Twiddlers Syndrome 41 41
Shock from Patient Lead(s) 40 40
Pericardial Effusion 38 38
Impaired Healing 33 33
Complaint, Ill-Defined 33 33
Non specific EKG/ECG Changes 31 31
Head Injury 29 29
Swelling 28 28
Cardiac Perforation 28 28
Perforation 27 27
Inflammation 26 26
Atrial Flutter 25 25
Failure of Implant 24 24
Muscle Weakness 24 24
Heart Block 22 22
Pneumothorax 21 21
Heart Failure 21 21
Cardiac Tamponade 20 20
Implant Pain 20 20
Vascular Dissection 19 19
Hemorrhage/Bleeding 19 19
Nausea 18 18
Complete Heart Block 18 18
Obstruction/Occlusion 18 18
Burning Sensation 17 17
Weakness 16 16
Abscess 16 16
Foreign Body In Patient 16 16
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
Headache 11 11
Seizures 11 11
Occlusion 10 10
Atrial Tachycardia 10 10
Bone Fracture(s) 9 9
Pleural Effusion 9 9
Injury 9 9
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
-
-