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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)
2019 2020 2021 2022 2023 2024
0 0 2 1 3 0

MDR Year MDR Reports MDR Events
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 860 860
Defective Device 588 588
Communication or Transmission Problem 386 386
Application Program Problem 97 97
Wireless Communication Problem 84 84
Display or Visual Feedback Problem 71 71
Data Problem 48 48
Failure to Power Up 48 48
Defective Component 35 35
Overheating of Device 31 31
Interrogation Problem 23 23
Detachment of Device or Device Component 22 22
No Display/Image 17 17
Connection Problem 17 17
Computer Software Problem 16 16
Application Program Freezes, Becomes Nonfunctional 14 14
Telemetry Discrepancy 12 12
Power Problem 10 10
Pacing Problem 10 10
Use of Device Problem 9 9
Incorrect Measurement 8 8
Device Sensing Problem 7 7
Material Integrity Problem 6 6
No Apparent Adverse Event 6 6
Electrical /Electronic Property Problem 5 5
Date/Time-Related Software Problem 5 5
Insufficient Information 5 5
Failure to Transmit Record 4 4
Device Displays Incorrect Message 4 4
Computer Operating System Problem 4 4
Unexpected Shutdown 3 3
Noise, Audible 3 3
Mechanical Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Intermittent Loss of Power 3 3
Program or Algorithm Execution Failure 3 3
Loss of Data 3 3
Smoking 3 3
Inappropriate Tactile Prompt/Feedback 2 2
Program or Algorithm Execution Problem 2 2
Operating System Version or Upgrade Problem 2 2
Failure to Reset 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Patient Data Problem 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
Over-Sensing 2 2
Human-Device Interface Problem 1 1
Computer System Security Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1685 1685
Insufficient Information 47 47
No Information 38 38
No Known Impact Or Consequence To Patient 32 32
No Consequences Or Impact To Patient 14 14
Asystole 10 10
Bradycardia 5 5
Syncope/Fainting 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Electric Shock 3 3
Arrhythmia 2 2
Shock from Patient Lead(s) 2 2
Head Injury 2 2
Cardiac Arrest 2 2
No Patient Involvement 2 2
Heart Failure/Congestive Heart Failure 2 2
Tachycardia 2 2
Unspecified Infection 1 1
Syncope 1 1
Failure of Implant 1 1
Burn(s) 1 1
Ventricular Fibrillation 1 1
Discomfort 1 1
Dyspnea 1 1
Fall 1 1
Swelling/ Edema 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 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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