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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 1063 1063
2024 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Key or Button Unresponsive/not Working 757 757
Defective Device 493 493
Communication or Transmission Problem 323 323
Application Program Problem 74 74
Wireless Communication Problem 64 64
Display or Visual Feedback Problem 64 64
Failure to Power Up 42 42
Data Problem 37 37
Defective Component 35 35
Overheating of Device 29 29
Detachment of Device or Device Component 21 21
Interrogation Problem 19 19
Connection Problem 14 14
No Display/Image 12 12
Computer Software Problem 11 11
Pacing Problem 10 10
Telemetry Discrepancy 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Device Sensing Problem 7 7
Incorrect Measurement 7 7
Use of Device Problem 6 6
Material Integrity Problem 6 6
Date/Time-Related Software Problem 5 5
No Apparent Adverse Event 5 5
Power Problem 5 5
Electrical /Electronic Property Problem 5 5
Computer Operating System Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 3 3
Program or Algorithm Execution Failure 3 3
Failure to Transmit Record 3 3
Failure to Reset 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Smoking 2 2
Mechanical Problem 2 2
Over-Sensing 2 2
Noise, Audible 2 2
Program or Algorithm Execution Problem 2 2
Inappropriate Tactile Prompt/Feedback 2 2
Intermittent Loss of Power 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
Loss of Data 2 2
Device Displays Incorrect Message 1 1
Application Network Problem 1 1
Operating System Version or Upgrade Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unauthorized Access to Computer System 1 1
Scratched Material 1 1
Patient Data Problem 1 1
Melted 1 1
Energy Output Problem 1 1
No Device Output 1 1
Loose or Intermittent Connection 1 1
Failure to Back-Up 1 1
Premature Discharge of Battery 1 1
Failure to Charge 1 1
Unintended Power Up 1 1
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Low impedance 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Shipping Damage or Problem 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1406 1406
Insufficient Information 44 44
No Information 38 38
No Known Impact Or Consequence To Patient 32 32
No Consequences Or Impact To Patient 14 14
Asystole 9 9
Syncope/Fainting 4 4
Bradycardia 4 4
Electric Shock 3 3
No Patient Involvement 2 2
Shock from Patient Lead(s) 2 2
Tachycardia 2 2
Arrhythmia 2 2
Cardiac Arrest 2 2
Head Injury 2 2
Heart Failure/Congestive Heart Failure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Swelling/ Edema 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Dyspnea 1 1
Fall 1 1
Syncope 1 1
Burn(s) 1 1
Ventricular Fibrillation 1 1
Discomfort 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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