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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 172 172

Device Problems MDRs with this Device Problem Events in those MDRs
Key or Button Unresponsive/not Working 799 799
Defective Device 524 524
Communication or Transmission Problem 356 356
Application Program Problem 85 85
Wireless Communication Problem 72 72
Display or Visual Feedback Problem 65 65
Failure to Power Up 45 45
Data Problem 43 43
Defective Component 35 35
Overheating of Device 29 29
Detachment of Device or Device Component 21 21
Interrogation Problem 20 20
Computer Software Problem 15 15
Connection Problem 14 14
Application Program Freezes, Becomes Nonfunctional 13 13
No Display/Image 12 12
Pacing Problem 10 10
Telemetry Discrepancy 10 10
Incorrect Measurement 8 8
Use of Device Problem 8 8
Device Sensing Problem 7 7
Material Integrity Problem 6 6
No Apparent Adverse Event 6 6
Electrical /Electronic Property Problem 5 5
Power Problem 5 5
Date/Time-Related Software Problem 5 5
Insufficient Information 5 5
Computer Operating System Problem 4 4
Failure to Transmit Record 4 4
Device Displays Incorrect Message 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Program or Algorithm Execution Failure 3 3
Loss of Data 3 3
Mechanical Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Noise, Audible 2 2
Program or Algorithm Execution Problem 2 2
Intermittent Loss of Power 2 2
Patient Data Problem 2 2
Inappropriate Tactile Prompt/Feedback 2 2
Over-Sensing 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Failure to Reset 2 2
Therapeutic or Diagnostic Output Failure 2 2
Smoking 2 2
Appropriate Term/Code Not Available 2 2
Failure to Charge 1 1
Shipping Damage or Problem 1 1
Component Missing 1 1
Melted 1 1
Device Difficult to Setup or Prepare 1 1
Inappropriate or Unexpected Reset 1 1
Premature Discharge of Battery 1 1
Unintended Power Up 1 1
Unauthorized Access to Computer System 1 1
Improper or Incorrect Procedure or Method 1 1
Energy Output Problem 1 1
Difficult to Interrogate 1 1
Low impedance 1 1
Product Quality Problem 1 1
Display Difficult to Read 1 1
Human-Device Interface Problem 1 1
Computer System Security Problem 1 1
Failure to Back-Up 1 1
Unexpected Shutdown 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
No Device Output 1 1
Packaging Problem 1 1
Output Problem 1 1
Impedance Problem 1 1
Image Orientation Incorrect 1 1
Loose or Intermittent Connection 1 1
Erratic or Intermittent Display 1 1
Unable to Obtain Readings 1 1
Thermal Decomposition of Device 1 1
Scratched Material 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 1535 1535
Insufficient Information 45 45
No Information 38 38
No Known Impact Or Consequence To Patient 32 32
No Consequences Or Impact To Patient 14 14
Asystole 9 9
Bradycardia 5 5
Syncope/Fainting 4 4
Electric Shock 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Shock from Patient Lead(s) 2 2
Head Injury 2 2
Cardiac Arrest 2 2
Arrhythmia 2 2
Heart Failure/Congestive Heart Failure 2 2
No Patient Involvement 2 2
Tachycardia 2 2
Syncope 1 1
Failure of Implant 1 1
Burn(s) 1 1
Discomfort 1 1
Ventricular Fibrillation 1 1
Unspecified Infection 1 1
Fall 1 1
Dyspnea 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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