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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulse generator, permanent, implantable
Definition Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Product CodeNVZ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
124 181 178 130 131 122 88 76 61 59 60 73 40 44 39 12

MDR Year MDR Reports MDR Events
2014 3105 3105
2015 2773 2773
2016 2554 2554
2017 3164 3164
2018 5877 5877
2019 8186 8186
2020 8337 8337
2021 8537 8537
2022 7791 7791
2023 8464 8464
2024 1680 1680

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12750 12750
Premature Discharge of Battery 7533 7533
Pacing Problem 6211 6211
Appropriate Term/Code Not Available 4582 4582
Battery Problem 4016 4016
Over-Sensing 3982 3982
Failure to Interrogate 3135 3135
Mechanical Problem 2481 2481
Inappropriate or Unexpected Reset 1503 1503
Unable to Obtain Readings 1498 1498
Failure to Capture 1457 1457
Incorrect Measurement 1278 1278
Pacemaker Found in Back-Up Mode 1197 1197
Inappropriate/Inadequate Shock/Stimulation 1059 1059
Defective Device 1011 1011
Signal Artifact/Noise 903 903
Under-Sensing 851 851
Overheating of Device 836 836
Communication or Transmission Problem 827 827
Reset Problem 802 802
High impedance 766 766
Device Sensing Problem 703 703
Migration or Expulsion of Device 674 674
Nonstandard Device 596 596
False Alarm 538 538
Insufficient Information 532 532
No Pacing 514 514
Incorrect Interpretation of Signal 511 511
Premature Elective Replacement Indicator 464 464
Electromagnetic Interference 454 454
Output Problem 434 434
Data Problem 420 420
Low impedance 402 402
Capturing Problem 387 387
High Capture Threshold 338 338
Loose or Intermittent Connection 295 295
Misconnection 289 289
Device Operates Differently Than Expected 283 283
Impedance Problem 280 280
Battery Problem: High Impedance 253 253
Electrical /Electronic Property Problem 243 243
Use of Device Problem 210 210
Break 194 194
Connection Problem 194 194
Failure to Deliver Shock/Stimulation 185 185
Missing Test Results 183 183
False Positive Result 176 176
Failure to Charge 171 171
Intermittent Capture 158 158
Failure to Disconnect 157 157
Delayed Charge Time 149 149
Protective Measures Problem 145 145
Interrogation Problem 141 141
Device Displays Incorrect Message 140 140
Incorrect, Inadequate or Imprecise Result or Readings 121 121
Device-Device Incompatibility 120 120
Thermal Decomposition of Device 118 118
Failure to Convert Rhythm 100 100
Therapeutic or Diagnostic Output Failure 100 100
Premature End-of-Life Indicator 95 95
Pocket Stimulation 92 92
Pacing Inadequately 89 89
Device Emits Odor 89 89
Pacing Asynchronously 88 88
Wireless Communication Problem 87 87
Difficult to Remove 83 83
Device Dislodged or Dislocated 78 78
Display or Visual Feedback Problem 76 76
Positioning Problem 72 72
Failure to Sense 68 68
Invalid Sensing 65 65
Noise, Audible 64 64
Battery Impedance Issue 62 62
Output above Specifications 62 62
Low Battery 58 58
Component Missing 55 55
Therapy Delivered to Incorrect Body Area 53 53
Pacing Intermittently 52 52
Telemetry Discrepancy 49 49
Unstable Capture Threshold 49 49
Environmental Compatibility Problem 46 46
No Apparent Adverse Event 43 43
Difficult to Interrogate 42 42
Device Contamination with Body Fluid 40 40
Migration 40 40
Ambient Noise Problem 39 39
Loss of Data 38 38
Decreased Sensitivity 37 37
Fitting Problem 33 33
Failure to Power Up 32 32
Defibrillation/Stimulation Problem 32 32
Device Markings/Labelling Problem 30 30
Energy Output Problem 29 29
Device Expiration Issue 28 28
Defective Alarm 28 28
Power Problem 27 27
Packaging Problem 27 27
Charging Problem 25 25
Fracture 25 25
No Device Output 25 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 18805 18809
No Clinical Signs, Symptoms or Conditions 15611 15611
Unspecified Infection 7906 7906
No Consequences Or Impact To Patient 2370 2370
Insufficient Information 2000 2000
Bradycardia 1974 1974
Dizziness 1159 1159
Death 1144 1144
Arrhythmia 945 945
Discomfort 900 900
Syncope 861 861
Pocket Erosion 804 804
Dyspnea 773 773
Syncope/Fainting 766 766
Pain 684 684
No Code Available 554 554
No Information 532 532
Therapeutic Effects, Unexpected 523 523
Cardiac Arrest 489 489
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 461 461
Chest Pain 459 459
Fatigue 457 457
Erosion 434 434
Tachycardia 426 426
Complaint, Ill-Defined 421 421
Endocarditis 396 396
Sepsis 381 381
Hematoma 375 375
Bacterial Infection 367 367
Fall 315 315
Atrial Fibrillation 312 312
Non specific EKG/ECG Changes 265 265
Palpitations 247 247
Wound Dehiscence 228 228
No Patient Involvement 206 206
Erythema 187 187
Fever 181 181
Heart Block 172 172
Ventricular Tachycardia 151 151
Swelling/ Edema 144 144
Ventricular Fibrillation 143 143
Muscle Stimulation 143 143
Weakness 136 136
Low Blood Pressure/ Hypotension 120 120
Asystole 111 111
Muscle Weakness 109 109
Swelling 97 97
Purulent Discharge 94 94
Device Overstimulation of Tissue 91 91
Hypersensitivity/Allergic reaction 87 87
Foreign Body In Patient 83 83
Loss of consciousness 83 83
Heart Failure/Congestive Heart Failure 69 69
Complete Heart Block 67 67
Presyncope 66 66
Impaired Healing 66 66
Heart Failure 65 65
Nausea 64 64
Undesired Nerve Stimulation 62 62
Fainting 62 62
Inflammation 60 60
Twiddlers Syndrome 60 60
Pericardial Effusion 60 60
Exit Block 60 60
Cardiomyopathy 59 59
Drug Resistant Bacterial Infection 58 58
Fluid Discharge 55 55
Burning Sensation 54 54
Chest Tightness/Pressure 53 53
Stroke/CVA 51 51
Myocardial Infarction 51 51
High Blood Pressure/ Hypertension 51 51
Shock from Patient Lead(s) 49 49
Failure of Implant 48 48
Atrial Flutter 47 47
Anxiety 47 47
Pneumothorax 45 45
Headache 44 44
Septic Shock 43 43
Lethargy 42 42
Electric Shock 37 37
Hemorrhage/Bleeding 36 36
Burn(s) 34 34
Sleep Dysfunction 34 34
Implant Pain 34 34
Bruise/Contusion 33 33
Itching Sensation 33 33
Pneumonia 32 32
Convulsion/Seizure 32 32
Numbness 31 31
Vomiting 31 31
Rash 31 31
Congestive Heart Failure 31 31
Seizures 29 29
Twitching 29 29
Confusion/ Disorientation 28 28
Diaphoresis 27 27
Thrombosis/Thrombus 27 27
Twiddlers Syndrome 26 26
Necrosis 25 25

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-29-2011
2 Medtronic Inc. Cardiac Rhythm Disease Managment II Aug-11-2010
3 Medtronic Inc. Cardiac Rhythm Disease Managment I Jun-11-2009
4 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-19-2018
5 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jul-05-2016
6 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-04-2016
7 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Dec-16-2021
8 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2020
9 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-14-2019
10 St Jude Medical Cardiac Rhythm Management Division II Sep-28-2015
11 St Jude Medical Cardiac Rhythm Management Division II Jan-09-2015
12 St Jude Medical, Cardiac Rhythm Management Division II Feb-24-2020
13 St. Jude Medical, Cardian Rhythm Management Division I May-07-2021
14 ela Medical Llc II Sep-24-2009
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