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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 120 120

Device Problems MDRs with this Device Problem Events in those MDRs
Key or Button Unresponsive/not Working 782 782
Defective Device 510 510
Communication or Transmission Problem 352 352
Application Program Problem 85 85
Wireless Communication Problem 72 72
Device Operates Differently Than Expected 65 65
Display or Visual Feedback Problem 64 64
Failure to Power Up 59 59
Data Problem 42 42
Defective Component 35 35
Overheating of Device 30 30
Computer Software Problem 26 26
Computer Operating System Problem 22 22
No Apparent Adverse Event 22 22
Detachment of Device or Device Component 21 21
Power Problem 20 20
Interrogation Problem 19 19
Pacing Problem 18 18
Connection Problem 14 14
No Display/Image 13 13
Telemetry Discrepancy 9 9
Application Program Freezes, Becomes Nonfunctional 9 9
Material Integrity Problem 8 8
Device Displays Incorrect Message 8 8
Use of Device Problem 8 8
Device Sensing Problem 8 8
Inadequate User Interface 8 8
Incorrect Measurement 8 8
Battery Problem 7 7
Electrical /Electronic Property Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 5 5
Over-Sensing 5 5
Failure to Transmit Record 5 5
Date/Time-Related Software Problem 5 5
Inappropriate/Inadequate Shock/Stimulation 5 5
Ambient Noise Problem 4 4
Mechanical Problem 4 4
Failure to Interrogate 4 4
Output Problem 4 4
Device Operational Issue 3 3
Device Packaging Compromised 3 3
Appropriate Term/Code Not Available 3 3
Patient Data Problem 3 3
Program or Algorithm Execution Failure 3 3
Loss of Data 3 3
Failure to Shut Off 3 3
Low impedance 2 2
Capturing Problem 2 2
Smoking 2 2
Under-Sensing 2 2
Device Inoperable 2 2
Detachment Of Device Component 2 2
High impedance 2 2
Premature Discharge of Battery 2 2
No Device Output 2 2
Failure to Reset 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Program or Algorithm Execution Problem 2 2
Inappropriate Tactile Prompt/Feedback 2 2
Intermittent Loss of Power 2 2
Noise, Audible 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unauthorized Access to Computer System 1 1
Scratched Material 1 1
Packaging Problem 1 1
Operating System Becomes Nonfunctional 1 1
Operating System Version or Upgrade Problem 1 1
Activation Problem 1 1
Shipping Damage or Problem 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Melted 1 1
Energy Output Problem 1 1
Failure to Charge 1 1
Device Alarm System 1 1
Failure to Back-Up 1 1
Unintended Power Up 1 1
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
Difficult to Interrogate 1 1
Loose or Intermittent Connection 1 1
Device Stops Intermittently 1 1
Invalid Sensing 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1
Application Network Problem 1 1
Low Battery 1 1
Improper or Incorrect Procedure or Method 1 1
Computer System Security Problem 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
Inappropriate or Unexpected Reset 1 1
Installation-Related Problem 1 1
Issue With Displayed Error Message 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1483 1483
No Known Impact Or Consequence To Patient 124 124
No Information 54 54
Insufficient Information 45 45
No Consequences Or Impact To Patient 45 45
No Patient Involvement 40 40
Asystole 9 9
Bradycardia 5 5
Syncope/Fainting 4 4
Complaint, Ill-Defined 3 3
Electric Shock 3 3
Arrhythmia 3 3
Unspecified Infection 3 3
Tachycardia 2 2
Head Injury 2 2
Cardiac Arrest 2 2
Dyspnea 2 2
Fall 2 2
Syncope 2 2
Shock from Patient Lead(s) 2 2
Heart Failure/Congestive Heart Failure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Swelling/ Edema 1 1
Fever 1 1
Cardiomyopathy 1 1
Death 1 1
Atrial Fibrillation 1 1
Atrial Flutter 1 1
Burn(s) 1 1
Failure of Implant 1 1
Discomfort 1 1
Ventricular Fibrillation 1 1
Dizziness 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
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