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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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)
2019 2020 2021 2022 2023 2024
29 30 26 24 27 9

MDR Year MDR Reports MDR Events
2019 794 794
2020 806 806
2021 1177 1177
2022 1290 1290
2023 1469 1469
2024 1014 1014

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1747 1747
Incorrect, Inadequate or Imprecise Result or Readings 1018 1018
Premature Discharge of Battery 905 905
Over-Sensing 764 764
Pacing Problem 699 699
High impedance 452 452
Signal Artifact/Noise 361 361
Failure to Capture 247 247
Defective Device 215 215
Unable to Obtain Readings 190 190
Low impedance 180 180
Battery Problem 172 172
Appropriate Term/Code Not Available 161 161
Inappropriate or Unexpected Reset 122 122
High Capture Threshold 114 114
Mechanical Problem 113 113
Under-Sensing 109 109
Failure to Interrogate 95 95
Impedance Problem 83 83
Device Sensing Problem 82 82
Incorrect Measurement 72 72
Interrogation Problem 71 71
Off-Label Use 66 66
Data Problem 64 64
False Alarm 62 62
Pacemaker Found in Back-Up Mode 58 58
Connection Problem 57 57
Failure to Read Input Signal 54 54
Loose or Intermittent Connection 47 47
Pocket Stimulation 44 44
Capturing Problem 43 43
Reset Problem 43 43
Misconnection 39 39
Telemetry Discrepancy 39 39
Electromagnetic Interference 34 34
Device Displays Incorrect Message 33 33
Insufficient Information 33 33
Migration or Expulsion of Device 33 33
No Pacing 32 32
Communication or Transmission Problem 31 31
Premature Elective Replacement Indicator 31 31
Use of Device Problem 25 25
False Positive Result 20 20
Wireless Communication Problem 17 17
Migration 16 16
Unexpected Therapeutic Results 13 13
Therapy Delivered to Incorrect Body Area 12 12
Intermittent Capture 10 10
Missing Test Results 10 10
Difficult to Insert 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2892 2892
Unspecified Infection 1366 1366
No Known Impact Or Consequence To Patient 665 665
Insufficient Information 213 213
No Code Available 195 195
Pocket Erosion 186 186
No Consequences Or Impact To Patient 179 179
Sepsis 178 178
Syncope/Fainting 177 177
Device Overstimulation of Tissue 158 158
Bradycardia 148 148
Asystole 121 121
Discomfort 110 110
Dizziness 109 109
Hematoma 88 88
Pain 66 66
Erosion 61 61
Dyspnea 59 59
Bacterial Infection 58 58
Syncope 42 42
Fall 41 41
Arrhythmia 40 40
Endocarditis 38 38
Presyncope 37 37
Wound Dehiscence 36 36
Death 36 36
Erythema 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Fatigue 34 34
Purulent Discharge 33 33
Chest Pain 31 31
Swelling/ Edema 31 31
Fever 26 26
Cardiac Arrest 26 26
Undesired Nerve Stimulation 24 24
Tachycardia 23 23
Muscle Stimulation 23 23
Unspecified Heart Problem 22 22
No Patient Involvement 19 19
Atrial Fibrillation 18 18
Heart Failure/Congestive Heart Failure 15 15
Drug Resistant Bacterial Infection 14 14
Loss of consciousness 14 14
Non specific EKG/ECG Changes 13 13
Failure of Implant 13 13
Malaise 12 12
Fluid Discharge 12 12
Head Injury 11 11
Pericardial Effusion 10 10
Septic Shock 10 10

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