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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)
2020 2021 2022 2023 2024 2025
73 40 44 39 42 15

MDR Year MDR Reports MDR Events
2020 8337 8337
2021 8537 8537
2022 7791 7791
2023 8467 8467
2024 6502 6502
2025 2505 2505

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10331 10331
Premature Discharge of Battery 4719 4719
Pacing Problem 4599 4599
Appropriate Term/Code Not Available 3104 3104
Over-Sensing 2882 2882
Failure to Interrogate 2398 2398
Mechanical Problem 1435 1435
Battery Problem 1181 1181
Defective Device 1131 1131
Inappropriate or Unexpected Reset 999 999
Failure to Capture 944 944
Pacemaker Found in Back-Up Mode 886 886
Unable to Obtain Readings 855 855
Inappropriate/Inadequate Shock/Stimulation 803 803
Signal Artifact/Noise 715 715
False Alarm 700 700
Incorrect Measurement 694 694
Overheating of Device 648 648
Under-Sensing 638 638
Reset Problem 594 594
Communication or Transmission Problem 527 527
Migration or Expulsion of Device 484 484
Electromagnetic Interference 444 444
Incorrect Interpretation of Signal 437 437
Insufficient Information 432 432
No Pacing 426 426
Device Sensing Problem 393 393
High impedance 355 355
Low impedance 330 330
Loose or Intermittent Connection 290 290
Premature Elective Replacement Indicator 276 276
Capturing Problem 258 258
Data Problem 241 241
Output Problem 236 236
Electrical /Electronic Property Problem 200 200
High Capture Threshold 186 186
Failure to Disconnect 182 182
Impedance Problem 163 163
Misconnection 160 160
Interrogation Problem 156 156
Use of Device Problem 148 148
Failure to Deliver Shock/Stimulation 147 147
Thermal Decomposition of Device 130 130
Failure to Charge 129 129
Break 115 115
Missing Test Results 108 108
Therapeutic or Diagnostic Output Failure 101 101
Pacing Asynchronously 100 100
Intermittent Capture 100 100
Incorrect, Inadequate or Imprecise Result or Readings 95 95

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19269 19269
Unspecified Infection 6475 6475
No Known Impact Or Consequence To Patient 2727 2727
Insufficient Information 2338 2338
No Consequences Or Impact To Patient 2085 2085
Bradycardia 1998 1998
Arrhythmia 1025 1025
Syncope/Fainting 982 982
Discomfort 922 922
Dizziness 824 824
Pocket Erosion 773 773
Dyspnea 589 589
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 568 568
Pain 545 545
Bacterial Infection 487 487
Tachycardia 438 438
Chest Pain 421 421
Erosion 419 419
Erythema 383 383
Fatigue 321 321
Sepsis 306 306
Swelling/ Edema 305 305
Atrial Fibrillation 269 269
Endocarditis 266 266
Cardiac Arrest 265 265
Hematoma 244 244
Fever 240 240
Wound Dehiscence 231 231
Non specific EKG/ECG Changes 231 231
Purulent Discharge 224 224
Heart Block 223 223
Fall 222 222
Death 216 216
Therapeutic Effects, Unexpected 204 204
Asystole 172 172
Syncope 151 151
Muscle Weakness 134 134
Heart Failure/Congestive Heart Failure 110 110
Presyncope 106 106
No Code Available 106 106
Low Blood Pressure/ Hypotension 103 103
Device Overstimulation of Tissue 102 102
Ventricular Fibrillation 101 101
Drug Resistant Bacterial Infection 97 97
No Information 88 88
Foreign Body In Patient 82 82
Loss of consciousness 81 81
Hypersensitivity/Allergic reaction 75 75
Cardiomyopathy 73 73
Failure of Implant 61 61

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical III Nov-26-2024
2 Medtronic Inc. II Sep-13-2024
3 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Dec-16-2021
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2020
5 Medtronic, Inc. II Jun-06-2025
6 St Jude Medical, Cardiac Rhythm Management Division II Feb-24-2020
7 St. Jude Medical, Cardian Rhythm Management Division I May-07-2021
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