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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 419 419

Device Problems MDRs with this Device Problem Events in those MDRs
Key or Button Unresponsive/not Working 896 896
Defective Device 626 626
Communication or Transmission Problem 405 405
Application Program Problem 109 109
Wireless Communication Problem 84 84
Display or Visual Feedback Problem 74 74
Failure to Power Up 50 50
Data Problem 49 49
Defective Component 35 35
Overheating of Device 32 32
Interrogation Problem 26 26
Detachment of Device or Device Component 22 22
Connection Problem 21 21
No Display/Image 17 17
Power Problem 16 16
Computer Software Problem 16 16
Application Program Freezes, Becomes Nonfunctional 15 15
Telemetry Discrepancy 12 12
Pacing Problem 10 10
Use of Device Problem 9 9
Incorrect Measurement 8 8
Device Sensing Problem 7 7
No Apparent Adverse Event 6 6
Material Integrity Problem 6 6
Electrical /Electronic Property Problem 5 5
Insufficient Information 5 5
Date/Time-Related Software Problem 5 5
Device Displays Incorrect Message 4 4
Failure to Transmit Record 4 4
Computer Operating System Problem 4 4
Noise, Audible 3 3
Intermittent Loss of Power 3 3
Loss of Data 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Unexpected Shutdown 3 3
Mechanical Problem 3 3
Smoking 3 3
Program or Algorithm Execution Failure 3 3
Failure to Charge 2 2
Program or Algorithm Execution Problem 2 2
Inappropriate Tactile Prompt/Feedback 2 2
Intermittent Communication Failure 2 2
Sparking 2 2
Operating System Version or Upgrade Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Patient Data Problem 2 2
Failure to Reset 2 2
Therapeutic or Diagnostic Output Failure 2 2
Over-Sensing 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1776 1776
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 11 11
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
Chest Pain 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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