• 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 pacemaker/icd/crt non-implanted components
Definition Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Product CodeOSR
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 1 1 2 8 8 3 1 0 0 0 2 1 3 0

MDR Year MDR Reports MDR Events
2014 8 8
2015 46 46
2016 29 29
2017 40 40
2018 57 57
2019 39 39
2020 39 39
2021 100 100
2022 257 257
2023 1065 1065
2024 326 326

Device Problems MDRs with this Device Problem Events in those MDRs
Key or Button Unresponsive/not Working 861 861
Defective Device 595 595
Communication or Transmission Problem 394 394
Application Program Problem 100 100
Wireless Communication Problem 88 88
Display or Visual Feedback Problem 71 71
Device Operates Differently Than Expected 65 65
Failure to Power Up 63 63
Data Problem 48 48
Defective Component 35 35
Overheating of Device 32 32
Computer Software Problem 28 28
Power Problem 25 25
Interrogation Problem 23 23
Computer Operating System Problem 22 22
Detachment of Device or Device Component 22 22
No Apparent Adverse Event 22 22
No Display/Image 18 18
Pacing Problem 18 18
Connection Problem 17 17
Application Program Freezes, Becomes Nonfunctional 14 14
Telemetry Discrepancy 12 12
Device Displays Incorrect Message 9 9
Use of Device Problem 9 9
Inadequate User Interface 8 8
Incorrect Measurement 8 8
Device Sensing Problem 8 8
Material Integrity Problem 8 8
Battery Problem 7 7
Electrical /Electronic Property Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 6 6
Inappropriate/Inadequate Shock/Stimulation 5 5
Failure to Transmit Record 5 5
Over-Sensing 5 5
Date/Time-Related Software Problem 5 5
Mechanical Problem 5 5
Failure to Interrogate 4 4
Ambient Noise Problem 4 4
Output Problem 4 4
Failure to Shut Off 4 4
Patient Data Problem 3 3
Smoking 3 3
Program or Algorithm Execution Failure 3 3
Device Packaging Compromised 3 3
Appropriate Term/Code Not Available 3 3
Device Operational Issue 3 3
Intermittent Loss of Power 3 3
Unexpected Shutdown 3 3
Noise, Audible 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1685 1685
No Known Impact Or Consequence To Patient 124 124
No Information 54 54
Insufficient Information 47 47
No Consequences Or Impact To Patient 45 45
No Patient Involvement 40 40
Asystole 10 10
Bradycardia 5 5
Syncope/Fainting 4 4
Unspecified Infection 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Arrhythmia 3 3
Complaint, Ill-Defined 3 3
Electric Shock 3 3
Syncope 2 2
Shock from Patient Lead(s) 2 2
Head Injury 2 2
Cardiac Arrest 2 2
Dyspnea 2 2
Fall 2 2
Heart Failure/Congestive Heart Failure 2 2
Tachycardia 2 2
Death 1 1
Failure of Implant 1 1
Dizziness 1 1
Atrial Fibrillation 1 1
Burn(s) 1 1
Fever 1 1
Ventricular Fibrillation 1 1
Discomfort 1 1
Cardiomyopathy 1 1
Swelling/ Edema 1 1
Atrial Flutter 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Nov-24-2021
2 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Apr-30-2021
3 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Mar-19-2020
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-30-2019
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Feb-16-2019
6 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Feb-02-2019
7 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Nov-08-2018
8 St Jude Medical Inc. II Jun-29-2018
9 St Jude Medical Inc. II Jun-12-2018
10 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
-
-