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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 120 120

Device Problems MDRs with this Device Problem Events in those MDRs
Key or Button Unresponsive/not Working 781 781
Defective Device 503 503
Communication or Transmission Problem 344 344
Application Program Problem 82 82
Wireless Communication Problem 68 68
Display or Visual Feedback Problem 64 64
Failure to Power Up 44 44
Data Problem 42 42
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
Computer Software Problem 14 14
No Display/Image 12 12
Pacing Problem 10 10
Telemetry Discrepancy 9 9
Application Program Freezes, Becomes Nonfunctional 9 9
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
Failure to Transmit Record 4 4
Computer Operating System Problem 4 4
Insufficient Information 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
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
Noise, Audible 2 2
Mechanical Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 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
Failure to Back-Up 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
Packaging Problem 1 1
No Device Output 1 1
Output Problem 1 1
Impedance Problem 1 1
Loose or Intermittent Connection 1 1
Erratic or Intermittent Display 1 1
Unable to Obtain Readings 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1483 1483
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
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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