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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)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
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
Application Program Freezes, Becomes Nonfunctional 9 9
Telemetry Discrepancy 9 9
Inadequate User Interface 8 8
Device Displays Incorrect Message 8 8
Incorrect Measurement 8 8
Use of Device Problem 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
Failure to Transmit Record 5 5
Inappropriate/Inadequate Shock/Stimulation 5 5
Over-Sensing 5 5
Date/Time-Related Software Problem 5 5
Insufficient Information 5 5
Mechanical Problem 4 4
Output Problem 4 4
Ambient Noise Problem 4 4
Failure to Interrogate 4 4
Appropriate Term/Code Not Available 3 3
Device Operational Issue 3 3
Program or Algorithm Execution Failure 3 3
Loss of Data 3 3
Failure to Shut Off 3 3
Patient Data Problem 3 3
Device Packaging Compromised 3 3
Under-Sensing 2 2
Program or Algorithm Execution Problem 2 2
Intermittent Loss of Power 2 2
Inappropriate Tactile Prompt/Feedback 2 2
Detachment Of Device Component 2 2
Noise, Audible 2 2
No Device Output 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Inoperable 2 2
Low impedance 2 2
Capturing Problem 2 2
Smoking 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Reset 2 2
High impedance 2 2
Premature Discharge of Battery 2 2
Invalid Sensing 1 1
Inappropriate or Unexpected Reset 1 1
Unintended Power Up 1 1
Unauthorized Access to Computer System 1 1
Activation Problem 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Charge 1 1
Shipping Damage or Problem 1 1
Component Missing 1 1
Melted 1 1
Issue With Displayed Error Message 1 1
Device Stops Intermittently 1 1
Tear, Rip or Hole in Device Packaging 1 1
Product Quality Problem 1 1
Display Difficult to Read 1 1
Energy Output Problem 1 1
Difficult to Interrogate 1 1
Improper or Incorrect Procedure or Method 1 1
Human-Device Interface Problem 1 1
Operating System Becomes Nonfunctional 1 1
Computer System Security Problem 1 1
Packaging Problem 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Impedance Problem 1 1
Loose or Intermittent Connection 1 1
Erratic or Intermittent Display 1 1
Unable to Obtain Readings 1 1
Device Alarm System 1 1
Low Battery 1 1
Failure to Back-Up 1 1
Installation-Related Problem 1 1
Application Network Problem 1 1
Incomplete or Missing Packaging 1 1
Operating System Version or Upgrade 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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