• 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)
2019 2020 2021 2022 2023 2024
29 30 26 24 27 6

MDR Year MDR Reports MDR Events
2019 794 794
2020 806 806
2021 1177 1177
2022 1290 1290
2023 1469 1469
2024 649 649

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1669 1669
Incorrect, Inadequate or Imprecise Result or Readings 940 940
Premature Discharge of Battery 866 866
Over-Sensing 716 716
Pacing Problem 639 639
High impedance 437 437
Signal Artifact/Noise 336 336
Failure to Capture 231 231
Defective Device 200 200
Unable to Obtain Readings 187 187
Low impedance 174 174
Battery Problem 164 164
Appropriate Term/Code Not Available 148 148
Inappropriate or Unexpected Reset 121 121
Mechanical Problem 106 106
High Capture Threshold 102 102
Under-Sensing 93 93
Failure to Interrogate 89 89
Impedance Problem 82 82
Device Sensing Problem 81 81
Interrogation Problem 69 69
Incorrect Measurement 69 69
Off-Label Use 63 63
Data Problem 63 63
Pacemaker Found in Back-Up Mode 58 58
Connection Problem 57 57
False Alarm 53 53
Loose or Intermittent Connection 47 47
Failure to Read Input Signal 47 47
Pocket Stimulation 42 42
Reset Problem 41 41
Capturing Problem 40 40
Telemetry Discrepancy 37 37
Misconnection 37 37
Electromagnetic Interference 33 33
Device Displays Incorrect Message 33 33
Migration or Expulsion of Device 32 32
Insufficient Information 31 31
No Pacing 30 30
Premature Elective Replacement Indicator 30 30
Communication or Transmission Problem 26 26
Use of Device Problem 22 22
False Positive Result 19 19
Wireless Communication Problem 16 16
Migration 15 15
Unexpected Therapeutic Results 13 13
Therapy Delivered to Incorrect Body Area 10 10
Intermittent Capture 10 10
Difficult to Insert 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
Protective Measures Problem 7 7
Device Dislodged or Dislocated 7 7
Inaccurate Synchronization 7 7
Difficult to Remove 7 7
Patient-Device Incompatibility 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
Product Quality Problem 5 5
Failure to Sense 4 4
Difficult to Interrogate 4 4
Contamination of Device Ingredient or Reagent 4 4
Human-Device Interface Problem 4 4
No Apparent Adverse Event 4 4
Battery Problem: High Impedance 3 3
Break 3 3
Misassembled 3 3
Ambient Noise Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Inappropriate/Inadequate Shock/Stimulation 2 2
Nonstandard Device 2 2
Output above Specifications 2 2
Pacing Inadequately 2 2
Device-Device Incompatibility 2 2
Unstable Capture Threshold 2 2
Noise, Audible 2 2
Packaging Problem 2 2
Unintended Electrical Shock 2 2
Intermittent Energy Output 1 1
Material Too Soft/Flexible 1 1
Positioning Problem 1 1
Unauthorized Access to Computer System 1 1
Unintended Movement 1 1
Temperature Problem 1 1
Loss of Data 1 1
Device Damaged by Another Device 1 1
High Sensing Threshold 1 1
Delayed Charge Time 1 1
Energy Output Problem 1 1
Device Alarm System 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Discolored 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2688 2688
Unspecified Infection 1305 1305
No Known Impact Or Consequence To Patient 665 665
Insufficient Information 204 204
No Code Available 195 195
No Consequences Or Impact To Patient 179 179
Pocket Erosion 176 176
Sepsis 171 171
Syncope/Fainting 166 166
Device Overstimulation of Tissue 146 146
Bradycardia 123 123
Asystole 112 112
Dizziness 101 101
Discomfort 101 101
Hematoma 87 87
Pain 58 58
Erosion 55 55
Dyspnea 53 53
Bacterial Infection 52 52
Syncope 42 42
Fall 39 39
Death 36 36
Arrhythmia 36 36
Endocarditis 35 35
Fatigue 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Wound Dehiscence 32 32
Purulent Discharge 31 31
Presyncope 31 31
Erythema 30 30
Chest Pain 30 30
Cardiac Arrest 26 26
Swelling/ Edema 26 26
Fever 25 25
Muscle Stimulation 23 23
Undesired Nerve Stimulation 23 23
Tachycardia 21 21
Unspecified Heart Problem 20 20
No Patient Involvement 19 19
Atrial Fibrillation 17 17
Failure of Implant 13 13
Heart Failure/Congestive Heart Failure 13 13
Drug Resistant Bacterial Infection 12 12
Loss of consciousness 12 12
Malaise 11 11
Fluid Discharge 11 11
Head Injury 11 11
Non specific EKG/ECG Changes 11 11
Pericardial Effusion 10 10
Anxiety 8 8
Complaint, Ill-Defined 8 8
Hemorrhage/Bleeding 8 8
Nausea 8 8
Septic Shock 8 8
Muscle Weakness 7 7
Inflammation 7 7
Low Blood Pressure/ Hypotension 7 7
Hypoxia 7 7
Chills 7 7
Twiddlers Syndrome 7 7
Ventricular Fibrillation 7 7
Swelling 7 7
Heart Block 6 6
Impaired Healing 6 6
Hypersensitivity/Allergic reaction 6 6
Cellulitis 5 5
Stroke/CVA 5 5
Palpitations 5 5
Respiratory Failure 5 5
Twitching 5 5
Vomiting 4 4
Burning Sensation 4 4
Skin Erosion 4 4
Staphylococcus Aureus 4 4
Thrombus 4 4
Thrombosis/Thrombus 4 4
Headache 4 4
Itching Sensation 4 4
Necrosis 4 4
Pleural Effusion 4 4
Pneumothorax 4 4
Skin Inflammation/ Irritation 4 4
Implant Pain 3 3
Respiratory Distress 3 3
Pneumonia 3 3
Hiccups 3 3
Pulmonary Edema 3 3
Myocardial Infarction 3 3
Diarrhea 3 3
Cardiomyopathy 3 3
Atrial Flutter 3 3
Abscess 3 3
Convulsion/Seizure 3 3
Inadequate Pain Relief 3 3
Weakness 3 3
Cardiac Tamponade 3 3
Cardiogenic Shock 3 3
Injury 2 2
Scar Tissue 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
-
-