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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 1

MDR Year MDR Reports MDR Events
2019 794 794
2020 806 806
2021 1177 1177
2022 1290 1290
2023 1469 1469
2024 383 383

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1609 1609
Incorrect, Inadequate or Imprecise Result or Readings 895 895
Premature Discharge of Battery 834 834
Over-Sensing 668 668
Pacing Problem 583 583
High impedance 432 432
Signal Artifact/Noise 317 317
Failure to Capture 216 216
Defective Device 192 192
Unable to Obtain Readings 187 187
Low impedance 168 168
Battery Problem 158 158
Appropriate Term/Code Not Available 142 142
Inappropriate or Unexpected Reset 115 115
Mechanical Problem 104 104
High Capture Threshold 98 98
Failure to Interrogate 86 86
Impedance Problem 82 82
Device Sensing Problem 80 80
Under-Sensing 76 76
Incorrect Measurement 67 67
Interrogation Problem 67 67
Data Problem 63 63
Off-Label Use 59 59
Pacemaker Found in Back-Up Mode 58 58
Connection Problem 53 53
False Alarm 51 51
Loose or Intermittent Connection 46 46
Failure to Read Input Signal 44 44
Pocket Stimulation 41 41
Reset Problem 41 41
Capturing Problem 38 38
Misconnection 37 37
Telemetry Discrepancy 36 36
Device Displays Incorrect Message 33 33
Migration or Expulsion of Device 32 32
Electromagnetic Interference 31 31
No Pacing 29 29
Premature Elective Replacement Indicator 27 27
Insufficient Information 26 26
Communication or Transmission Problem 24 24
Use of Device Problem 21 21
False Positive Result 17 17
Wireless Communication Problem 16 16
Migration 14 14
Unexpected Therapeutic Results 12 12
Therapy Delivered to Incorrect Body Area 10 10
Difficult to Insert 9 9
Intermittent Capture 9 9
Electrical /Electronic Property Problem 8 8
Failure to Disconnect 8 8
Missing Test Results 8 8
Therapeutic or Diagnostic Output Failure 8 8
Output Problem 8 8
Device Dislodged or Dislocated 7 7
Protective Measures Problem 7 7
Patient-Device Incompatibility 7 7
Inaccurate Synchronization 7 7
Difficult to Remove 7 7
Pacing Asynchronously 6 6
Material Integrity Problem 6 6
Fitting Problem 6 6
Premature End-of-Life Indicator 5 5
Pacing Intermittently 5 5
Display or Visual Feedback Problem 5 5
Difficult to Interrogate 4 4
Failure to Sense 4 4
Product Quality Problem 4 4
Contamination of Device Ingredient or Reagent 4 4
Human-Device Interface Problem 4 4
Battery Problem: High Impedance 3 3
No Apparent Adverse Event 3 3
Improper or Incorrect Procedure or Method 3 3
Break 3 3
Misassembled 3 3
Nonstandard Device 2 2
Output above Specifications 2 2
Pacing Inadequately 2 2
Ambient Noise Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Unstable Capture Threshold 2 2
Noise, Audible 2 2
Packaging Problem 2 2
Device-Device Incompatibility 2 2
Unintended Electrical Shock 2 2
Intermittent Energy Output 1 1
Loss of Data 1 1
Device Damaged by Another Device 1 1
Positioning Problem 1 1
Material Too Soft/Flexible 1 1
Unauthorized Access to Computer System 1 1
Unintended Movement 1 1
Temperature Problem 1 1
Failure to Select Signal 1 1
Device Difficult to Program or Calibrate 1 1
Failure to Convert Rhythm 1 1
Incorrect Interpretation of Signal 1 1
Self-Activation or Keying 1 1
Sensing Intermittently 1 1
Application Program Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2536 2536
Unspecified Infection 1254 1254
No Known Impact Or Consequence To Patient 665 665
Insufficient Information 198 198
No Code Available 195 195
No Consequences Or Impact To Patient 179 179
Pocket Erosion 168 168
Sepsis 168 168
Syncope/Fainting 153 153
Device Overstimulation of Tissue 140 140
Bradycardia 108 108
Asystole 102 102
Dizziness 97 97
Discomfort 94 94
Hematoma 86 86
Pain 55 55
Dyspnea 52 52
Bacterial Infection 50 50
Erosion 49 49
Syncope 42 42
Fall 38 38
Death 36 36
Endocarditis 35 35
Arrhythmia 35 35
Fatigue 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Wound Dehiscence 30 30
Purulent Discharge 30 30
Chest Pain 29 29
Presyncope 29 29
Erythema 28 28
Fever 25 25
Cardiac Arrest 25 25
Swelling/ Edema 25 25
Muscle Stimulation 23 23
Undesired Nerve Stimulation 22 22
No Patient Involvement 19 19
Tachycardia 19 19
Unspecified Heart Problem 19 19
Atrial Fibrillation 16 16
Failure of Implant 12 12
Heart Failure/Congestive Heart Failure 12 12
Drug Resistant Bacterial Infection 12 12
Fluid Discharge 11 11
Loss of consciousness 11 11
Head Injury 11 11
Non specific EKG/ECG Changes 10 10
Pericardial Effusion 10 10
Malaise 9 9
Complaint, Ill-Defined 8 8
Hemorrhage/Bleeding 8 8
Nausea 8 8
Inflammation 7 7
Hypoxia 7 7
Septic Shock 7 7
Chills 7 7
Swelling 7 7
Ventricular Fibrillation 7 7
Twiddlers Syndrome 7 7
Anxiety 7 7
Impaired Healing 6 6
Low Blood Pressure/ Hypotension 6 6
Hypersensitivity/Allergic reaction 6 6
Heart Block 6 6
Muscle Weakness 5 5
Cellulitis 5 5
Stroke/CVA 5 5
Palpitations 5 5
Twitching 5 5
Burning Sensation 4 4
Vomiting 4 4
Skin Erosion 4 4
Thrombus 4 4
Respiratory Failure 4 4
Thrombosis/Thrombus 4 4
Headache 4 4
Necrosis 4 4
Itching Sensation 4 4
Pneumothorax 4 4
Staphylococcus Aureus 4 4
Pleural Effusion 4 4
Pneumonia 3 3
Pulmonary Edema 3 3
Myocardial Infarction 3 3
Hiccups 3 3
Diarrhea 3 3
Cardiomyopathy 3 3
Atrial Flutter 3 3
Abscess 3 3
Convulsion/Seizure 3 3
Respiratory Distress 3 3
Weakness 3 3
Cardiac Tamponade 3 3
Skin Inflammation/ Irritation 3 3
Implant Pain 2 2
Tricuspid Valve Insufficiency/ Regurgitation 2 2
Limb Fracture 2 2
Cardiogenic Shock 2 2
Injury 2 2
Ventricular Tachycardia 2 2

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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