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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 13

MDR Year MDR Reports MDR Events
2014 3106 3106
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 2278 2278

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12928 12928
Premature Discharge of Battery 7595 7595
Pacing Problem 6295 6295
Appropriate Term/Code Not Available 4644 4644
Battery Problem 4025 4025
Over-Sensing 4011 4011
Failure to Interrogate 3172 3172
Mechanical Problem 2510 2510
Inappropriate or Unexpected Reset 1510 1510
Unable to Obtain Readings 1501 1501
Failure to Capture 1465 1465
Incorrect Measurement 1285 1285
Pacemaker Found in Back-Up Mode 1200 1200
Inappropriate/Inadequate Shock/Stimulation 1062 1062
Defective Device 1029 1029
Signal Artifact/Noise 908 908
Under-Sensing 860 860
Overheating of Device 837 837
Communication or Transmission Problem 834 834
Reset Problem 812 812
High impedance 772 772
Device Sensing Problem 703 703
Migration or Expulsion of Device 682 682
Nonstandard Device 596 596
False Alarm 549 549
Insufficient Information 537 537
No Pacing 524 524
Incorrect Interpretation of Signal 511 511
Premature Elective Replacement Indicator 468 468
Electromagnetic Interference 457 457
Output Problem 438 438
Data Problem 423 423
Low impedance 406 406
Capturing Problem 391 391
High Capture Threshold 338 338
Loose or Intermittent Connection 300 300
Misconnection 293 293
Device Operates Differently Than Expected 283 283
Impedance Problem 281 281
Battery Problem: High Impedance 254 254
Electrical /Electronic Property Problem 244 244
Use of Device Problem 210 210
Break 196 196
Connection Problem 194 194
Failure to Deliver Shock/Stimulation 186 186
Missing Test Results 183 183
False Positive Result 176 176
Failure to Charge 172 172
Failure to Disconnect 161 161
Intermittent Capture 158 158
Delayed Charge Time 149 149
Protective Measures Problem 146 146
Interrogation Problem 141 141
Device Displays Incorrect Message 141 141
Thermal Decomposition of Device 124 124
Incorrect, Inadequate or Imprecise Result or Readings 121 121
Device-Device Incompatibility 121 121
Failure to Convert Rhythm 101 101
Therapeutic or Diagnostic Output Failure 100 100
Premature End-of-Life Indicator 95 95
Pocket Stimulation 92 92
Pacing Asynchronously 89 89
Pacing Inadequately 89 89
Device Emits Odor 89 89
Wireless Communication Problem 87 87
Difficult to Remove 84 84
Device Dislodged or Dislocated 78 78
Display or Visual Feedback Problem 76 76
Positioning Problem 73 73
Failure to Sense 68 68
Noise, Audible 67 67
Invalid Sensing 65 65
Output above Specifications 62 62
Battery Impedance Issue 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 47 47
No Apparent Adverse Event 44 44
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
Failure to Power Up 34 34
Fitting Problem 33 33
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
Packaging Problem 28 28
Power 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 18806 18810
No Clinical Signs, Symptoms or Conditions 15909 15909
Unspecified Infection 8026 8026
No Consequences Or Impact To Patient 2370 2370
Insufficient Information 2029 2029
Bradycardia 2020 2020
Dizziness 1175 1175
Death 1144 1144
Arrhythmia 964 964
Discomfort 916 916
Syncope 861 861
Pocket Erosion 822 822
Dyspnea 789 789
Syncope/Fainting 780 780
Pain 696 696
No Code Available 554 554
No Information 532 532
Therapeutic Effects, Unexpected 523 523
Cardiac Arrest 491 491
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 471 471
Chest Pain 466 466
Fatigue 462 462
Erosion 449 449
Tachycardia 436 436
Complaint, Ill-Defined 421 421
Endocarditis 398 398
Sepsis 395 395
Bacterial Infection 389 389
Hematoma 377 377
Atrial Fibrillation 320 320
Fall 316 316
Non specific EKG/ECG Changes 270 270
Palpitations 247 247
Wound Dehiscence 240 240
No Patient Involvement 206 206
Erythema 201 201
Fever 190 190
Heart Block 175 175
Swelling/ Edema 158 158
Ventricular Tachycardia 151 151
Ventricular Fibrillation 144 144
Muscle Stimulation 143 143
Weakness 136 136
Low Blood Pressure/ Hypotension 122 122
Asystole 115 115
Muscle Weakness 112 112
Purulent Discharge 105 105
Swelling 97 97
Device Overstimulation of Tissue 92 92
Hypersensitivity/Allergic reaction 87 87
Loss of consciousness 84 84
Foreign Body In Patient 83 83
Heart Failure/Congestive Heart Failure 72 72
Impaired Healing 68 68
Complete Heart Block 67 67
Presyncope 67 67
Nausea 67 67
Heart Failure 65 65
Cardiomyopathy 63 63
Fainting 62 62
Undesired Nerve Stimulation 62 62
Inflammation 61 61
Pericardial Effusion 61 61
Exit Block 60 60
Twiddlers Syndrome 60 60
Drug Resistant Bacterial Infection 60 60
Fluid Discharge 55 55
Burning Sensation 54 54
Chest Tightness/Pressure 53 53
High Blood Pressure/ Hypertension 52 52
Stroke/CVA 52 52
Myocardial Infarction 51 51
Failure of Implant 49 49
Shock from Patient Lead(s) 49 49
Anxiety 47 47
Atrial Flutter 47 47
Headache 45 45
Pneumothorax 45 45
Septic Shock 43 43
Lethargy 42 42
Electric Shock 37 37
Hemorrhage/Bleeding 37 37
Bruise/Contusion 35 35
Burn(s) 34 34
Sleep Dysfunction 34 34
Implant Pain 34 34
Numbness 33 33
Itching Sensation 33 33
Rash 32 32
Pneumonia 32 32
Convulsion/Seizure 32 32
Vomiting 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
Hypoxia 26 26

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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