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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)
2017 2018 2019 2020 2021 2022
48 29 29 30 26 10

MDR Year MDR Reports MDR Events
2017 607 607
2018 1005 1005
2019 795 795
2020 806 806
2021 1177 1177
2022 764 764

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1523 1523
Premature Discharge of Battery 578 578
Over-Sensing 531 531
High impedance 440 440
Pacing Problem 394 394
Incorrect, Inadequate or Imprecise Resultor Readings 381 381
Inappropriate or Unexpected Reset 238 238
Unable to Obtain Readings 218 218
Signal Artifact/Noise 178 178
Failure to Capture 159 159
Pacemaker Found in Back-Up Mode 158 158
Reset Problem 137 137
Low impedance 134 134
Ambient Noise Problem 115 115
Defective Device 103 103
Appropriate Term/Code Not Available 101 101
Mechanical Problem 100 100
Device Sensing Problem 100 100
Battery Problem 92 92
Device Operates Differently Than Expected 87 87
Failure to Interrogate 81 81
Device Displays Incorrect Message 70 70
Impedance Problem 70 70
Incorrect Measurement 63 63
Data Problem 62 62
High Capture Threshold 53 53
Connection Problem 50 50
Use of Device Problem 48 48
Capturing Problem 44 44
Under-Sensing 41 41
Misconnection 41 41
Pocket Stimulation 40 40
Off-Label Use 40 40
Telemetry Discrepancy 37 37
False Alarm 37 37
Communication or Transmission Problem 33 33
Operating System Version or Upgrade Problem 33 33
Interrogation Problem 32 32
Migration or Expulsion of Device 26 26
Premature Elective Replacement Indicator 24 24
Loose or Intermittent Connection 24 24
No Pacing 24 24
Nonstandard Device 20 20
Electromagnetic Interference 20 20
Difficult to Interrogate 17 17
Output Problem 15 15
Insufficient Information 12 12
Failure to Read Input Signal 12 12
Migration 11 11
False Positive Result 11 11
Difficult to Insert 11 11
Electrical /Electronic Property Problem 11 11
Intermittent Capture 11 11
Protective Measures Problem 10 10
Fitting Problem 10 10
Material Integrity Problem 9 9
Wireless Communication Problem 9 9
Missing Test Results 8 8
Pacing Intermittently 8 8
Patient-Device Incompatibility 7 7
Difficult to Remove 6 6
Pacing Inadequately 6 6
Unexpected Therapeutic Results 6 6
Premature End-of-Life Indicator 6 6
Display or Visual Feedback Problem 6 6
No Device Output 5 5
Device Dislodged or Dislocated 5 5
Pacing Asynchronously 5 5
Failure to Disconnect 5 5
Failure to Sense 5 5
Human-Device Interface Problem 4 4
Break 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Alarm System 3 3
Device Difficult to Program or Calibrate 3 3
Problem with Software Installation 3 3
Battery Problem: High Impedance 3 3
Inaccurate Synchronization 3 3
Application Program Problem 3 3
Application Program Version or Upgrade Problem 3 3
Failure to Convert Rhythm 3 3
Power Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Loss of Data 3 3
Device Contamination With Biological Material 2 2
Improper or Incorrect Procedure or Method 2 2
Device Contamination with Body Fluid 2 2
Product Quality Problem 2 2
Out-Of-Box Failure 2 2
Incorrect Interpretation of Signal 2 2
Programming Issue 2 2
Unintended Electrical Shock 2 2
Misassembled 2 2
No Apparent Adverse Event 2 2
Noise, Audible 2 2
Material Too Soft/Flexible 1 1
Intermittent Energy Output 1 1
Labelling, Instructions for Use or Training Problem 1 1
Shelf Life Exceeded 1 1
Battery Problem: Low Impedance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1463 1463
No Clinical Signs, Symptoms or Conditions 1174 1174
Unspecified Infection 1172 1172
No Consequences Or Impact To Patient 277 277
Sepsis 218 218
No Code Available 208 208
Pocket Erosion 145 145
Insufficient Information 117 117
Death 114 114
Hematoma 93 93
Syncope 91 91
Dizziness 77 77
Bradycardia 71 71
Syncope/Fainting 64 64
Discomfort 60 60
Erosion 58 58
Device Overstimulation of Tissue 57 57
No Patient Involvement 54 54
Muscle Stimulation 49 49
Pain 45 45
Dyspnea 45 45
Complaint, Ill-Defined 38 38
Fatigue 36 36
Endocarditis 32 32
Fall 31 31
Asystole 29 29
Arrhythmia 29 29
Chest Pain 25 25
Wound Dehiscence 24 24
Cardiac Arrest 22 22
Undesired Nerve Stimulation 22 22
Swelling 20 20
Bacterial Infection 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Atrial Fibrillation 17 17
Erythema 15 15
Fever 15 15
Palpitations 14 14
No Information 13 13
Tachycardia 11 11
Twiddlers Syndrome 11 11
Purulent Discharge 10 10
Presyncope 10 10
Head Injury 9 9
Weakness 9 9
Pneumothorax 9 9
Pericardial Effusion 8 8
Non specific EKG/ECG Changes 8 8
Swelling/ Edema 8 8
Nausea 7 7
Septic Shock 7 7
Low Blood Pressure/ Hypotension 7 7
Inflammation 7 7
Staphylococcus Aureus 7 7
Pleural Effusion 7 7
Ventricular Fibrillation 6 6
Thrombus 6 6
Ventricular Tachycardia 6 6
Chills 6 6
Cellulitis 6 6
Bruise/Contusion 5 5
Unspecified Heart Problem 5 5
Failure of Implant 5 5
Burning Sensation 5 5
Pneumonia 4 4
Itching Sensation 4 4
Impaired Healing 4 4
Congestive Heart Failure 4 4
Heart Failure/Congestive Heart Failure 4 4
Complete Heart Block 4 4
Malaise 4 4
Loss of consciousness 4 4
Necrosis 4 4
Hemorrhage/Bleeding 4 4
Hypoxia 4 4
Myocardial Infarction 4 4
Heart Failure 4 4
Skin Inflammation/ Irritation 3 3
Pulmonary Edema 3 3
Fluid Discharge 3 3
Irritation 3 3
Thrombosis 3 3
Fainting 3 3
Abscess 3 3
Atrial Tachycardia 3 3
Hiccups 3 3
Loss Of Pulse 3 3
Headache 3 3
Vomiting 3 3
Injury 3 3
Respiratory Distress 3 3
Seizures 2 2
Cardiogenic Shock 2 2
Diarrhea 2 2
Laceration(s) 2 2
Limb Fracture 2 2
Rash 2 2
Muscle Weakness 2 2
Vascular Dissection 2 2
Shock from Patient Lead(s) 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 Boston Scientific Corporation II Jan-15-2018
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Apr-30-2021
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2018
6 St Jude Medical Inc. II Jun-12-2018
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