• 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 8

MDR Year MDR Reports MDR Events
2020 806 806
2021 1177 1177
2022 1290 1290
2023 1469 1469
2024 1519 1519
2025 705 705

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1754 1754
Incorrect, Inadequate or Imprecise Result or Readings 1237 1237
Premature Discharge of Battery 981 981
Over-Sensing 817 817
Pacing Problem 797 797
High impedance 435 435
Signal Artifact/Noise 423 423
Failure to Capture 292 292
Defective Device 276 276
Battery Problem 206 206
Appropriate Term/Code Not Available 184 184
Low impedance 170 170
Unable to Obtain Readings 152 152
Under-Sensing 139 139
High Capture Threshold 127 127
Mechanical Problem 112 112
Failure to Interrogate 98 98
Inappropriate or Unexpected Reset 91 91
Interrogation Problem 91 91
False Alarm 83 83
Failure to Read Input Signal 74 74
Impedance Problem 71 71
Connection Problem 65 65
Incorrect Measurement 65 65
Data Problem 62 62
Off-Label Use 59 59
Loose or Intermittent Connection 59 59
Pocket Stimulation 48 48
Capturing Problem 47 47
Telemetry Discrepancy 47 47
Device Sensing Problem 44 44
Pacemaker Found in Back-Up Mode 43 43
Migration or Expulsion of Device 42 42
Insufficient Information 41 41
Electromagnetic Interference 36 36
Premature Elective Replacement Indicator 31 31
Communication or Transmission Problem 30 30
No Pacing 30 30
Use of Device Problem 28 28
Misconnection 27 27
Reset Problem 23 23
False Positive Result 20 20
Migration 18 18
Unexpected Therapeutic Results 14 14
Therapy Delivered to Incorrect Body Area 14 14
Inaccurate Synchronization 13 13
Failure to Disconnect 12 12
Wireless Communication Problem 12 12
Electrical /Electronic Property Problem 11 11
Intermittent Capture 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3581 3581
Unspecified Infection 1356 1356
No Known Impact Or Consequence To Patient 263 263
Insufficient Information 242 242
Syncope/Fainting 222 222
Device Overstimulation of Tissue 196 196
No Code Available 191 191
Pocket Erosion 186 186
Bradycardia 184 184
Sepsis 159 159
No Consequences Or Impact To Patient 144 144
Asystole 144 144
Discomfort 134 134
Dizziness 119 119
Hematoma 83 83
Pain 80 80
Bacterial Infection 78 78
Erosion 73 73
Dyspnea 73 73
Arrhythmia 61 61
Erythema 59 59
Swelling/ Edema 49 49
Fall 48 48
Purulent Discharge 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 43 43
Wound Dehiscence 43 43
Presyncope 42 42
Fever 39 39
Fatigue 38 38
Chest Pain 38 38
Endocarditis 33 33
Tachycardia 29 29
Unspecified Heart Problem 28 28
Cardiac Arrest 26 26
Undesired Nerve Stimulation 26 26
Loss of consciousness 23 23
Syncope 22 22
Drug Resistant Bacterial Infection 21 21
Heart Failure/Congestive Heart Failure 19 19
Atrial Fibrillation 18 18
Muscle Stimulation 16 16
Fluid Discharge 15 15
Death 14 14
Failure of Implant 14 14
Malaise 14 14
Non specific EKG/ECG Changes 11 11
Head Injury 11 11
Anxiety 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
-
-