Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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)
2018 2019 2020 2021 2022 2023
29 29 30 26 24 18

MDR Year MDR Reports MDR Events
2018 1004 1004
2019 794 794
2020 806 806
2021 1177 1177
2022 1290 1290
2023 987 987

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1698 1698
Premature Discharge of Battery 761 761
Incorrect, Inadequate or Imprecise Result or Readings 712 712
Over-Sensing 646 646
Pacing Problem 534 534
High impedance 471 471
Signal Artifact/Noise 264 264
Inappropriate or Unexpected Reset 247 247
Unable to Obtain Readings 223 223
Failure to Capture 203 203
Defective Device 170 170
Low impedance 159 159
Reset Problem 140 140
Appropriate Term/Code Not Available 134 134
Battery Problem 130 130
Mechanical Problem 115 115
Pacemaker Found in Back-Up Mode 111 111
Device Sensing Problem 106 106
Failure to Interrogate 90 90
Impedance Problem 87 87
Ambient Noise Problem 81 81
High Capture Threshold 79 79
Data Problem 74 74
Incorrect Measurement 70 70
Under-Sensing 61 61
Device Displays Incorrect Message 58 58
Interrogation Problem 56 56
Off-Label Use 52 52
Connection Problem 51 51
False Alarm 48 48
Misconnection 45 45
Capturing Problem 43 43
Pocket Stimulation 42 42
Telemetry Discrepancy 40 40
Loose or Intermittent Connection 38 38
Use of Device Problem 37 37
Failure to Read Input Signal 30 30
Migration or Expulsion of Device 30 30
Premature Elective Replacement Indicator 29 29
Communication or Transmission Problem 29 29
Insufficient Information 28 28
Electromagnetic Interference 28 28
No Pacing 26 26
Device Operates Differently Than Expected 22 22
Operating System Version or Upgrade Problem 21 21
Nonstandard Device 21 21
False Positive Result 15 15
Migration 14 14
Output Problem 12 12
Wireless Communication Problem 11 11
Intermittent Capture 11 11
Electrical /Electronic Property Problem 10 10
Difficult to Insert 10 10
Protective Measures Problem 10 10
Fitting Problem 9 9
Patient-Device Incompatibility 8 8
Therapeutic or Diagnostic Output Failure 8 8
Missing Test Results 8 8
Therapy Delivered to Incorrect Body Area 8 8
Unexpected Therapeutic Results 8 8
Failure to Disconnect 8 8
Difficult to Remove 7 7
Material Integrity Problem 7 7
Device Dislodged or Dislocated 6 6
Premature End-of-Life Indicator 6 6
Difficult to Interrogate 6 6
Display or Visual Feedback Problem 5 5
Pacing Asynchronously 5 5
Break 5 5
Pacing Intermittently 5 5
Inaccurate Synchronization 5 5
Human-Device Interface Problem 5 5
Contamination of Device Ingredient or Reagent 4 4
Failure to Sense 4 4
Product Quality Problem 4 4
Pacing Inadequately 4 4
Output above Specifications 3 3
Device Difficult to Program or Calibrate 3 3
Loss of Data 3 3
Application Program Problem 3 3
Application Program Version or Upgrade Problem 3 3
Battery Problem: High Impedance 3 3
Power Problem 3 3
No Apparent Adverse Event 3 3
Unintended Electrical Shock 2 2
Unstable Capture Threshold 2 2
Noise, Audible 2 2
Positioning Problem 2 2
Failure to Convert Rhythm 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
High Sensing Threshold 2 2
Device Contamination with Body Fluid 2 2
Improper or Incorrect Procedure or Method 2 2
Misassembled 2 2
Device Alarm System 2 2
Circuit Failure 1 1
Component Falling 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Discolored 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2030 2030
Unspecified Infection 1319 1319
No Known Impact Or Consequence To Patient 1207 1207
No Consequences Or Impact To Patient 247 247
No Code Available 204 204
Sepsis 197 197
Insufficient Information 181 181
Pocket Erosion 168 168
Syncope/Fainting 124 124
Device Overstimulation of Tissue 106 106
Dizziness 95 95
Hematoma 93 93
Bradycardia 90 90
Discomfort 83 83
Syncope 75 75
Asystole 72 72
Death 69 69
Erosion 57 57
Dyspnea 56 56
Pain 47 47
Fall 43 43
Bacterial Infection 43 43
Muscle Stimulation 36 36
Endocarditis 36 36
Fatigue 35 35
No Patient Involvement 33 33
Arrhythmia 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Cardiac Arrest 29 29
Complaint, Ill-Defined 29 29
Chest Pain 28 28
Undesired Nerve Stimulation 25 25
Wound Dehiscence 24 24
Fever 23 23
Erythema 20 20
Purulent Discharge 19 19
Presyncope 19 19
Tachycardia 16 16
Swelling 15 15
Atrial Fibrillation 15 15
Swelling/ Edema 15 15
Head Injury 14 14
Non specific EKG/ECG Changes 13 13
Pericardial Effusion 11 11
Heart Failure/Congestive Heart Failure 11 11
Unspecified Heart Problem 10 10
Failure of Implant 10 10
Low Blood Pressure/ Hypotension 9 9
Malaise 9 9
Septic Shock 9 9
Drug Resistant Bacterial Infection 9 9
Chills 8 8
Fluid Discharge 8 8
Inflammation 8 8
Nausea 8 8
Pneumothorax 7 7
Hemorrhage/Bleeding 7 7
Cellulitis 7 7
Palpitations 7 7
Ventricular Fibrillation 7 7
Twiddlers Syndrome 7 7
Staphylococcus Aureus 6 6
Weakness 6 6
Anxiety 6 6
Loss of consciousness 6 6
Hypoxia 6 6
Pleural Effusion 6 6
Heart Block 6 6
Necrosis 5 5
Headache 5 5
Twitching 5 5
Vomiting 4 4
Burning Sensation 4 4
Ventricular Tachycardia 4 4
Thrombus 4 4
Respiratory Failure 4 4
Impaired Healing 4 4
No Information 4 4
Itching Sensation 4 4
Muscle Weakness 4 4
Myocardial Infarction 4 4
Pneumonia 4 4
Stroke/CVA 4 4
Abscess 4 4
Bruise/Contusion 3 3
Atrial Flutter 3 3
Atrial Tachycardia 3 3
Diarrhea 3 3
Pulmonary Edema 3 3
Fainting 3 3
Hiccups 3 3
Hypersensitivity/Allergic reaction 3 3
Irritation 3 3
Injury 3 3
Respiratory Distress 3 3
Skin Erosion 3 3
Cardiac Tamponade 3 3
Thrombosis/Thrombus 3 3
Skin Inflammation/ Irritation 3 3
Tricuspid Valve Insufficiency/ Regurgitation 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
-
-