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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)
2017 2018 2019 2020 2021 2022
1 0 0 0 2 1

MDR Year MDR Reports MDR Events
2017 40 40
2018 57 57
2019 39 39
2020 39 39
2021 100 100
2022 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 121 121
Device Operates Differently Than Expected 54 54
Wireless Communication Problem 35 35
Overheating of Device 26 26
Defective Component 21 21
No Apparent Adverse Event 17 17
Defective Device 15 15
Failure to Power Up 14 14
Data Problem 9 9
Display or Visual Feedback Problem 7 7
Pacing Problem 6 6
Application Program Problem 6 6
Electrical /Electronic Property Problem 5 5
Interrogation Problem 5 5
Detachment of Device or Device Component 5 5
Inadequate User Interface 4 4
Power Problem 4 4
Material Integrity Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 3 3
Device Operational Issue 3 3
Device Packaging Compromised 3 3
Use of Device Problem 3 3
Device Displays Incorrect Message 2 2
Device Sensing Problem 2 2
Computer Operating System Problem 2 2
Connection Problem 2 2
No Display/Image 2 2
Failure to Transmit Record 2 2
Failure to Reset 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Smoking 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unauthorized Access to Computer System 1 1
Issue With Displayed Error Message 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Patient Data Problem 1 1
Noise, Audible 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Activation Problem 1 1
Intermittent Loss of Power 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Device Difficult to Setup or Prepare 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Melted 1 1
Energy Output Problem 1 1
No Device Output 1 1
Over-Sensing 1 1
Detachment Of Device Component 1 1
Computer Software Problem 1 1
Unintended Power Up 1 1
Capturing Problem 1 1
Human-Device Interface Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Low impedance 1 1
Invalid Sensing 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 179 179
No Known Impact Or Consequence To Patient 96 96
No Information 51 51
No Consequences Or Impact To Patient 30 30
No Patient Involvement 9 9
Insufficient Information 5 5
Asystole 3 3
Bradycardia 3 3
Cardiac Arrest 2 2
Syncope 2 2
Head Injury 2 2
Tachycardia 2 2
Complaint, Ill-Defined 2 2
Electric Shock 2 2
Heart Failure/Congestive Heart Failure 2 2
Swelling/ Edema 1 1
Syncope/Fainting 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Shock from Patient Lead(s) 1 1
Dizziness 1 1
Discomfort 1 1
Failure of Implant 1 1
Arrhythmia 1 1
Death 1 1
Fall 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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