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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)
2015 2016 2017 2018 2019 2020
88 76 61 59 60 62

MDR Year MDR Reports MDR Events
2015 2767 2767
2016 2552 2552
2017 3151 3151
2018 5874 5874
2019 8173 8173
2020 6797 6797

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5500 5500
Premature Discharge of Battery 3576 3576
Battery Problem 3322 3322
Pacing Problem 2808 2808
Appropriate Term/Code Not Available 2416 2416
Over-Sensing 1872 1872
Mechanical Problem 1452 1452
Failure to Interrogate 1238 1238
Unable to Obtain Readings 919 919
Inappropriate or Unexpected Reset 787 787
Incorrect Measurement 771 771
Failure to Capture 699 699
Inappropriate/Inadequate Shock/Stimulation 531 531
Pacemaker Found in Back-Up Mode 458 458
Communication or Transmission Problem 435 435
Device Sensing Problem 417 417
Signal Artifact/Noise 399 399
High impedance 381 381
Under-Sensing 376 376
Reset Problem 349 349
Overheating of Device 348 348
Migration or Expulsion of Device 328 328
Nonstandard Device 318 318
Data Problem 271 271
Premature Elective Replacement Indicator 263 263
Output Problem 242 242
Device Operates Differently Than Expected 217 217
Incorrect Interpretation of Signal 215 215
Capturing Problem 210 210
Misconnection 191 191
No Pacing 190 190
High Capture Threshold 190 190
Insufficient Information 183 183
Battery Problem: High Impedance 172 172
False Alarm 172 172
Electromagnetic Interference 151 151
Impedance Problem 139 139
Low impedance 131 131
Screw 120 120
Protective Measures Problem 110 110
Missing Test Results 109 109
Break 109 109
Electrical /Electronic Property Problem 109 109
Use of Device Problem 107 107
Delayed Charge Time 106 106
Device Displays Incorrect Message 104 104
False Positive Result 104 104
Failure to Deliver Shock/Stimulation 88 88
Failure to Charge 84 84
Connection Problem 81 81
Intermittent Capture 79 79
Loose or Intermittent Connection 76 76
Wireless Communication Problem 59 59
Premature End-of-Life Indicator 54 54
Battery Impedance Issue 50 50
Thermal Decomposition of Device 47 47
Device Emits Odor 47 47
Pacing Inadequately 47 47
Telemetry Discrepancy 46 46
Invalid Sensing 46 46
Pocket Stimulation 43 43
Incorrect, Inadequate or Imprecise Resultor Readings 43 43
Positioning Problem 42 42
Device-Device Incompatibility 40 40
Output above Specifications 33 33
Display or Visual Feedback Problem 33 33
Failure to Convert Rhythm 32 32
Loss of Data 32 32
Pacing Intermittently 31 31
Unstable Capture Threshold 30 30
Difficult to Interrogate 30 30
Defibrillation/Stimulation Problem 29 29
Device Contamination with Body Fluid 28 28
Device Dislodged or Dislocated 27 27
Component Missing 26 26
Defective Alarm 26 26
Ambient Noise Problem 26 26
Failure to Sense 25 25
Interrogation Problem 24 24
Decreased Sensitivity 24 24
Migration 24 24
Noise, Audible 23 23
Patient Lead 22 22
Failure to Disconnect 21 21
Fitting Problem 21 21
Header 21 21
Energy Output Problem 20 20
Power Problem 20 20
Device Expiration Issue 19 19
No Device Output 18 18
Pacing Asynchronously 18 18
Defective Device 16 16
Difficult to Remove 15 15
Device Markings/Labelling Problem 14 14
Incorrect Or Inadequate Test Results 13 13
Separation Failure 12 12
Use of Incorrect Control Settings 12 12
Programming Issue 12 12
Device Damaged by Another Device 12 12
Device Contamination with Chemical or Other Material 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 17009 17010
Unspecified Infection 3633 3633
No Consequences Or Impact To Patient 1613 1613
Death 983 983
Syncope 748 748
Bradycardia 567 567
Dizziness 562 562
Therapeutic Effects, Unexpected 482 482
No Information 448 448
No Code Available 411 411
Pain 348 348
Complaint, Ill-Defined 344 344
Dyspnea 341 341
Pocket Erosion 292 292
Cardiac Arrest 281 281
Discomfort 280 280
Palpitations 216 216
Endocarditis 209 209
Hematoma 205 205
Erosion 204 204
Fatigue 203 203
Arrhythmia 198 198
Sepsis 191 191
Chest Pain 166 166
No Patient Involvement 159 159
Fall 154 154
Ventricular Tachycardia 128 128
Muscle Stimulation 117 117
Weakness 112 112
Atrial Fibrillation 111 111
Non specific EKG/ECG Changes 104 104
Tachycardia 102 102
Wound Dehiscence 94 94
Swelling 87 87
Ventricular Fibrillation 85 85
Fever 68 68
Complete Heart Block 57 57
Heart Failure 57 57
Exit Block 54 54
Twiddlers Syndrome 50 50
Low Blood Pressure/ Hypotension 46 46
Chest Tightness/Pressure 45 45
Bacterial Infection 43 43
Fainting 42 42
Undesired Nerve Stimulation 41 41
Hypersensitivity/Allergic reaction 39 39
Erythema 36 36
Syncope/Fainting 35 35
Burning Sensation 33 33
Congestive Heart Failure 31 31
Inflammation 31 31
Shock from Patient Lead(s) 29 29
Seizures 27 27
Anxiety 26 26
Electric Shock 26 26
Impaired Healing 24 24
Nausea 24 24
Pericardial Effusion 24 24
Headache 23 23
Stroke/CVA 22 22
Patient Problem/Medical Problem 22 22
Thrombosis 22 22
Atrial Tachycardia 20 20
Loss of consciousness 20 20
High Blood Pressure/ Hypertension 19 19
Septic Shock 19 19
Rash 18 18
Burn(s) 17 17
Lethargy 17 17
Myocardial Infarction 17 17
Pneumonia 16 16
Edema 16 16
Sleep Dysfunction 16 16
No Clinical Signs, Symptoms or Conditions 15 15
Cardiopulmonary Arrest 15 15
Staphylococcus Aureus 15 15
Pneumothorax 15 15
Necrosis 15 15
Twitching 15 15
Tingling 14 14
Numbness 14 14
Respiratory Failure 13 13
Renal Failure 13 13
Device Overstimulation of Tissue 13 13
Atrial Flutter 13 13
Vomiting 13 13
Confusion/ Disorientation 13 13
Itching Sensation 13 13
Shock 13 13
Bruise/Contusion 13 13
Pleural Effusion 12 12
Cardiomyopathy 12 12
Thrombus 12 12
Chills 11 11
Occlusion 11 11
Head Injury 11 11
Cellulitis 11 11
Bone Fracture(s) 11 11
Hypoxia 10 10
Irregular Pulse 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-19-2018
2 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jul-05-2016
3 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-04-2016
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2020
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-14-2019
6 St Jude Medical Cardiac Rhythm Management Division II Sep-28-2015
7 St Jude Medical Cardiac Rhythm Management Division II Jan-09-2015
8 St Jude Medical, Cardiac Rhythm Management Division II Feb-24-2020
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