• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Definition These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.
Product CodeNKE
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
30 26 24 27 23 1

MDR Year MDR Reports MDR Events
2020 806 806
2021 1177 1177
2022 1290 1290
2023 1469 1469
2024 1519 1519
2025 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1627 1627
Incorrect, Inadequate or Imprecise Result or Readings 1139 1139
Premature Discharge of Battery 894 894
Over-Sensing 753 753
Pacing Problem 733 733
High impedance 407 407
Signal Artifact/Noise 387 387
Failure to Capture 262 262
Defective Device 238 238
Battery Problem 192 192
Appropriate Term/Code Not Available 171 171
Low impedance 163 163
Unable to Obtain Readings 152 152
Under-Sensing 119 119
High Capture Threshold 117 117
Mechanical Problem 104 104
Failure to Interrogate 90 90
Inappropriate or Unexpected Reset 90 90
Interrogation Problem 78 78
False Alarm 68 68
Impedance Problem 67 67
Failure to Read Input Signal 65 65
Incorrect Measurement 61 61
Connection Problem 61 61
Off-Label Use 56 56
Data Problem 54 54
Loose or Intermittent Connection 53 53
Pocket Stimulation 45 45
Capturing Problem 45 45
Pacemaker Found in Back-Up Mode 43 43
Telemetry Discrepancy 41 41
Device Sensing Problem 41 41
Insufficient Information 39 39
Migration or Expulsion of Device 36 36
Electromagnetic Interference 34 34
Communication or Transmission Problem 29 29
No Pacing 28 28
Premature Elective Replacement Indicator 27 27
Misconnection 27 27
Use of Device Problem 25 25
Reset Problem 22 22
False Positive Result 20 20
Migration 16 16
Unexpected Therapeutic Results 14 14
Therapy Delivered to Incorrect Body Area 13 13
Wireless Communication Problem 12 12
Inaccurate Synchronization 10 10
Failure to Disconnect 9 9
Electrical /Electronic Property Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3228 3228
Unspecified Infection 1269 1269
No Known Impact Or Consequence To Patient 263 263
Insufficient Information 226 226
Syncope/Fainting 203 203
No Code Available 191 191
Device Overstimulation of Tissue 180 180
Pocket Erosion 174 174
Bradycardia 166 166
Sepsis 153 153
No Consequences Or Impact To Patient 144 144
Asystole 132 132
Discomfort 120 120
Dizziness 106 106
Hematoma 78 78
Pain 71 71
Bacterial Infection 67 67
Dyspnea 67 67
Erosion 63 63
Arrhythmia 51 51
Fall 47 47
Erythema 46 46
Presyncope 42 42
Purulent Discharge 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Wound Dehiscence 40 40
Swelling/ Edema 40 40
Chest Pain 36 36
Fatigue 36 36
Fever 35 35
Endocarditis 32 32
Tachycardia 27 27
Undesired Nerve Stimulation 25 25
Cardiac Arrest 25 25
Unspecified Heart Problem 24 24
Syncope 22 22
Loss of consciousness 19 19
Drug Resistant Bacterial Infection 19 19
Heart Failure/Congestive Heart Failure 17 17
Atrial Fibrillation 17 17
Muscle Stimulation 16 16
Fluid Discharge 15 15
Failure of Implant 14 14
Death 14 14
Malaise 13 13
Anxiety 11 11
Non specific EKG/ECG Changes 11 11
Head Injury 11 11
Hemorrhage/Bleeding 10 10
Muscle Weakness 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jan-10-2025
2 Boston Scientific Corporation I Jul-13-2021
3 Boston Scientific Corporation II Jul-02-2021
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Apr-30-2021
-
-