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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 17

MDR Year MDR Reports MDR Events
2019 794 794
2020 806 806
2021 1177 1177
2022 1290 1290
2023 1469 1469
2024 1275 1275

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1805 1805
Incorrect, Inadequate or Imprecise Result or Readings 1075 1075
Premature Discharge of Battery 927 927
Over-Sensing 803 803
Pacing Problem 739 739
High impedance 465 465
Signal Artifact/Noise 379 379
Failure to Capture 261 261
Defective Device 226 226
Unable to Obtain Readings 191 191
Low impedance 182 182
Battery Problem 176 176
Appropriate Term/Code Not Available 169 169
Inappropriate or Unexpected Reset 122 122
High Capture Threshold 118 118
Mechanical Problem 118 118
Under-Sensing 117 117
Failure to Interrogate 98 98
Impedance Problem 85 85
Device Sensing Problem 84 84
Incorrect Measurement 72 72
Interrogation Problem 71 71
False Alarm 68 68
Data Problem 67 67
Off-Label Use 66 66
Connection Problem 60 60
Failure to Read Input Signal 59 59
Pacemaker Found in Back-Up Mode 58 58
Loose or Intermittent Connection 52 52
Pocket Stimulation 48 48
Capturing Problem 46 46
Reset Problem 43 43
Telemetry Discrepancy 39 39
Misconnection 39 39
Insufficient Information 36 36
Migration or Expulsion of Device 36 36
Electromagnetic Interference 35 35
Device Displays Incorrect Message 33 33
No Pacing 32 32
Premature Elective Replacement Indicator 32 32
Communication or Transmission Problem 31 31
Use of Device Problem 26 26
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
Difficult to Insert 9 9
Missing Test Results 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3043 3043
Unspecified Infection 1416 1416
No Known Impact Or Consequence To Patient 665 665
Insufficient Information 218 218
No Code Available 195 195
Pocket Erosion 191 191
Syncope/Fainting 186 186
Sepsis 181 181
No Consequences Or Impact To Patient 179 179
Device Overstimulation of Tissue 171 171
Bradycardia 162 162
Asystole 126 126
Discomfort 116 116
Dizziness 115 115
Hematoma 90 90
Pain 71 71
Erosion 63 63
Dyspnea 59 59
Bacterial Infection 58 58
Arrhythmia 46 46
Fall 45 45
Syncope 42 42
Presyncope 40 40
Erythema 39 39
Endocarditis 38 38
Wound Dehiscence 37 37
Death 36 36
Purulent Discharge 35 35
Fatigue 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Swelling/ Edema 33 33
Chest Pain 31 31
Fever 30 30
Cardiac Arrest 26 26
Tachycardia 25 25
Undesired Nerve Stimulation 24 24
Muscle Stimulation 23 23
Unspecified Heart Problem 23 23
No Patient Involvement 19 19
Atrial Fibrillation 18 18
Failure of Implant 15 15
Heart Failure/Congestive Heart Failure 15 15
Drug Resistant Bacterial Infection 15 15
Loss of consciousness 14 14
Malaise 13 13
Fluid Discharge 13 13
Non specific EKG/ECG Changes 13 13
Head Injury 11 11
Hemorrhage/Bleeding 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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