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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)
2019 2020 2021 2022 2023 2024
60 73 40 44 39 10

MDR Year MDR Reports MDR Events
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 9955 9955
Premature Discharge of Battery 4637 4637
Pacing Problem 4305 4305
Appropriate Term/Code Not Available 3769 3769
Over-Sensing 3093 3093
Failure to Interrogate 2259 2259
Battery Problem 1947 1947
Mechanical Problem 1348 1348
Inappropriate or Unexpected Reset 1116 1116
Unable to Obtain Readings 1042 1042
Defective Device 992 992
Pacemaker Found in Back-Up Mode 951 951
Failure to Capture 930 930
Inappropriate/Inadequate Shock/Stimulation 896 896
Incorrect Measurement 856 856
Signal Artifact/Noise 787 787
Overheating of Device 722 722
Under-Sensing 651 651
Communication or Transmission Problem 586 586
Reset Problem 559 559
False Alarm 524 524
Incorrect Interpretation of Signal 475 475
Device Sensing Problem 470 470
Migration or Expulsion of Device 411 411
Electromagnetic Interference 410 410
Insufficient Information 400 400
No Pacing 396 396
High impedance 381 381
Low impedance 331 331
Data Problem 306 306
Premature Elective Replacement Indicator 269 269
Output Problem 259 259
Capturing Problem 258 258
Loose or Intermittent Connection 233 233
High Capture Threshold 202 202
Impedance Problem 188 188
Electrical /Electronic Property Problem 173 173
Misconnection 171 171
Failure to Deliver Shock/Stimulation 168 168
Failure to Charge 161 161
Failure to Disconnect 154 154
Use of Device Problem 144 144
Interrogation Problem 136 136
Break 126 126
Missing Test Results 122 122
Thermal Decomposition of Device 112 112
Protective Measures Problem 110 110
Therapeutic or Diagnostic Output Failure 98 98
Intermittent Capture 98 98
Failure to Convert Rhythm 96 96
Incorrect, Inadequate or Imprecise Result or Readings 93 93
False Positive Result 86 86
Pacing Asynchronously 81 81
Device-Device Incompatibility 79 79
Difficult to Remove 77 77
Wireless Communication Problem 76 76
Delayed Charge Time 73 73
Connection Problem 69 69
Device Emits Odor 64 64
Premature End-of-Life Indicator 55 55
Device Dislodged or Dislocated 55 55
Pocket Stimulation 54 54
Battery Problem: High Impedance 54 54
Noise, Audible 52 52
Therapy Delivered to Incorrect Body Area 52 52
Positioning Problem 48 48
Environmental Compatibility Problem 46 46
Display or Visual Feedback Problem 40 40
No Apparent Adverse Event 37 37
Migration 37 37
Component Missing 34 34
Failure to Sense 33 33
Failure to Power Up 32 32
Pacing Intermittently 28 28
Output above Specifications 27 27
Device Markings/Labelling Problem 27 27
Unstable Capture Threshold 26 26
Decreased Sensitivity 23 23
Charging Problem 23 23
Defective Alarm 22 22
Packaging Problem 22 22
Pacing Inadequately 21 21
Telemetry Discrepancy 20 20
Contamination of Device Ingredient or Reagent 19 19
Energy Output Problem 19 19
Tactile Prompts/Feedback 19 19
Melted 18 18
Fracture 17 17
Device Contamination with Body Fluid 16 16
Ambient Noise Problem 15 15
Product Quality Problem 15 15
Loss of Data 14 14
Separation Failure 14 14
Sensing Intermittently 14 14
Fitting Problem 13 13
Labelling, Instructions for Use or Training Problem 13 13
No Device Output 12 12
Moisture Damage 12 12
Human-Device Interface Problem 12 12
Material Integrity Problem 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15567 15567
No Known Impact Or Consequence To Patient 7910 7913
Unspecified Infection 6302 6302
No Consequences Or Impact To Patient 2089 2089
Insufficient Information 1997 1997
Bradycardia 1599 1599
Arrhythmia 839 839
Dizziness 799 799
Syncope/Fainting 764 764
Discomfort 741 741
Pocket Erosion 737 737
Death 573 573
Dyspnea 557 557
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 460 460
Pain 443 443
Therapeutic Effects, Unexpected 407 407
Chest Pain 373 373
Tachycardia 357 357
Syncope 355 355
Bacterial Infection 344 344
Erosion 325 325
Fatigue 310 310
Cardiac Arrest 282 282
Sepsis 264 264
Endocarditis 249 249
Hematoma 244 244
Atrial Fibrillation 228 228
Non specific EKG/ECG Changes 217 217
Fall 216 216
No Code Available 201 201
No Information 183 183
Erythema 174 174
Wound Dehiscence 173 173
Heart Block 172 172
Fever 154 154
Swelling/ Edema 143 143
Complaint, Ill-Defined 143 143
Asystole 111 111
Palpitations 110 110
Ventricular Fibrillation 109 109
Muscle Weakness 108 108
Low Blood Pressure/ Hypotension 92 92
Purulent Discharge 92 92
Ventricular Tachycardia 83 83
Foreign Body In Patient 82 82
Device Overstimulation of Tissue 78 78
Heart Failure/Congestive Heart Failure 69 69
Presyncope 66 66
Loss of consciousness 64 64
No Patient Involvement 63 63
Muscle Stimulation 63 63
Hypersensitivity/Allergic reaction 63 63
Drug Resistant Bacterial Infection 58 58
Swelling 53 53
Nausea 52 52
Cardiomyopathy 52 52
Fluid Discharge 52 52
Pericardial Effusion 51 51
Impaired Healing 50 50
Weakness 50 50
Myocardial Infarction 45 45
Undesired Nerve Stimulation 42 42
Failure of Implant 41 41
Inflammation 40 40
Stroke/CVA 39 39
High Blood Pressure/ Hypertension 38 38
Hemorrhage/Bleeding 34 34
Implant Pain 34 34
Convulsion/Seizure 32 32
Lethargy 32 32
Atrial Flutter 32 32
Burning Sensation 32 32
Anxiety 31 31
Complete Heart Block 30 30
Burn(s) 29 29
Sleep Dysfunction 27 27
Thrombosis/Thrombus 27 27
Twiddlers Syndrome 26 26
Bruise/Contusion 26 26
Itching Sensation 26 26
Vomiting 25 25
Septic Shock 25 25
Headache 25 25
Diaphoresis 25 25
Exit Block 24 24
Heart Failure 23 23
Pneumothorax 23 23
Rash 23 23
Twitching 21 21
Shock from Patient Lead(s) 21 21
Chills 20 20
Hypoxia 20 20
Pneumonia 19 19
Abscess 19 19
Numbness 19 19
Cardiac Perforation 19 19
Necrosis 18 18
Seizures 17 17
Twiddlers Syndrome 17 17
Confusion/ Disorientation 17 17

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Dec-16-2021
2 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2020
3 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-14-2019
4 St Jude Medical, Cardiac Rhythm Management Division II Feb-24-2020
5 St. Jude Medical, Cardian Rhythm Management Division I May-07-2021
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