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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)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
122 88 76 61 59 60 73 40 44 39 23

MDR Year MDR Reports MDR Events
2014 3107 3107
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 8466 8466
2024 4394 4394

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13479 13479
Premature Discharge of Battery 7831 7831
Pacing Problem 6679 6679
Appropriate Term/Code Not Available 4792 4792
Over-Sensing 4125 4125
Battery Problem 4048 4048
Failure to Interrogate 3288 3288
Mechanical Problem 2582 2582
Inappropriate or Unexpected Reset 1543 1543
Unable to Obtain Readings 1529 1529
Failure to Capture 1511 1511
Incorrect Measurement 1306 1306
Pacemaker Found in Back-Up Mode 1200 1200
Inappropriate/Inadequate Shock/Stimulation 1101 1101
Defective Device 1077 1077
Signal Artifact/Noise 930 930
Under-Sensing 885 885
Communication or Transmission Problem 857 857
Overheating of Device 850 850
Reset Problem 847 847
High impedance 790 790
Migration or Expulsion of Device 721 721
Device Sensing Problem 711 711
False Alarm 606 606
Nonstandard Device 596 596
Insufficient Information 563 563
No Pacing 544 544
Incorrect Interpretation of Signal 531 531
Electromagnetic Interference 488 488
Premature Elective Replacement Indicator 473 473
Output Problem 447 447
Data Problem 428 428
Low impedance 423 423
Capturing Problem 400 400
High Capture Threshold 346 346
Loose or Intermittent Connection 320 320
Misconnection 301 301
Impedance Problem 290 290
Device Operates Differently Than Expected 283 283
Electrical /Electronic Property Problem 261 261
Battery Problem: High Impedance 256 256
Use of Device Problem 218 218
Break 200 200
Failure to Deliver Shock/Stimulation 194 194
Connection Problem 194 194
Missing Test Results 187 187
False Positive Result 178 178
Failure to Charge 176 176
Failure to Disconnect 170 170
Intermittent Capture 161 161

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 16930 16930
Unspecified Infection 8412 8412
No Consequences Or Impact To Patient 2370 2370
Bradycardia 2219 2219
Insufficient Information 2137 2137
Dizziness 1228 1228
Death 1144 1144
Arrhythmia 1039 1039
Discomfort 992 992
Pocket Erosion 879 879
Syncope 861 861
Syncope/Fainting 849 849
Dyspnea 830 830
Pain 734 734
No Code Available 554 554
No Information 532 532
Therapeutic Effects, Unexpected 523 523
Cardiac Arrest 503 503
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 502 502
Chest Pain 502 502
Erosion 486 486
Fatigue 474 474
Tachycardia 458 458
Bacterial Infection 425 425
Complaint, Ill-Defined 421 421
Sepsis 412 412
Endocarditis 410 410
Hematoma 389 389
Fall 330 330
Atrial Fibrillation 325 325
Non specific EKG/ECG Changes 285 285
Wound Dehiscence 261 261
Erythema 256 256
Palpitations 247 247
Fever 211 211
No Patient Involvement 206 206
Swelling/ Edema 203 203
Heart Block 193 193
Ventricular Tachycardia 151 151
Ventricular Fibrillation 147 147
Purulent Discharge 143 143
Muscle Stimulation 143 143
Weakness 136 136
Asystole 136 136
Low Blood Pressure/ Hypotension 133 133
Muscle Weakness 124 124
Device Overstimulation of Tissue 99 99
Swelling 97 97
Loss of consciousness 92 92

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Sep-13-2024
2 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-19-2018
3 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jul-05-2016
4 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-04-2016
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Dec-16-2021
6 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2020
7 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-14-2019
8 St Jude Medical Cardiac Rhythm Management Division II Sep-28-2015
9 St Jude Medical Cardiac Rhythm Management Division II Jan-09-2015
10 St Jude Medical, Cardiac Rhythm Management Division II Feb-24-2020
11 St. Jude Medical, Cardian Rhythm Management Division I May-07-2021
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