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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)
2021 2022 2023 2024 2025 2026
2 1 3 0 2 0

MDR Year MDR Reports MDR Events
2021 103 103
2022 268 269
2023 1089 1096
2024 451 460
2025 8599 8599
2026 24151 61100

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 30691 67642
Computer Operating System Problem 27769 31461
Key or Button Unresponsive/not Working 1041 1042
Communication or Transmission Problem 1040 37991
Defective Device 730 730
Display or Visual Feedback Problem 187 188
Output Problem 178 37127
Application Program Problem 156 159
Data Problem 147 149
Application Program Freezes, Becomes Nonfunctional 79 33338
Wireless Communication Problem 69 70
Power Problem 63 63
Inadequate User Interface 62 37011
Failure to Power Up 55 55
Connection Problem 34 34
Defective Component 34 34
Device Difficult to Program or Calibrate 33 33
Overheating of Device 32 32
Interrogation Problem 32 32
Pacing Problem 27 27
Device Sensing Problem 26 26
Failure to Interrogate 24 24
No Display/Image 24 24
Detachment of Device or Device Component 23 23
Telemetry Discrepancy 19 20
Problem with Software Installation 14 14
Material Integrity Problem 11 11
Nonstandard Device 11 11
Mechanical Problem 10 10
Failure to Transmit Record 10 10
Use of Device Problem 10 10
Date/Time-Related Software Problem 10 10
Activation Problem 10 10
Insufficient Information 9 10
Device Displays Incorrect Message 9 9
Incorrect Measurement 8 8
Unexpected Shutdown 8 8
No Apparent Adverse Event 7 7
Thermal Decomposition of Device 7 7
Smoking 7 7
Inappropriate/Inadequate Shock/Stimulation 6 7
Capturing Problem 6 6
Failure to Charge 6 6
Electrical /Electronic Property Problem 6 6
Premature Discharge of Battery 6 7
Patient Device Interaction Problem 6 6
Activation Failure 5 5
Program or Algorithm Execution Failure 5 5
Melted 5 5
Sparking 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34539 71504
Insufficient Information 48 48
Asystole 21 21
Arrhythmia 12 12
Bradycardia 12 12
Syncope/Fainting 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Dizziness 6 6
No Information 6 6
Heart Block 5 5
No Known Impact Or Consequence To Patient 4 4
Tachycardia 4 4
Electric Shock 3 3
Cardiac Arrest 3 3
No Consequences Or Impact To Patient 3 3
Low Blood Pressure/ Hypotension 3 3
Shock from Patient Lead(s) 2 3
Presyncope 2 2
Head Injury 2 2
Pain 2 2
Heart Failure/Congestive Heart Failure 2 2
Shock 2 2
Loss of consciousness 2 2
Unspecified Infection 1 1
Burn(s) 1 1
Ventricular Fibrillation 1 1
Chest Pain 1 1
Dyspnea 1 1
Fall 1 1
Swelling/ Edema 1 1
Convulsion/Seizure 1 1
Headache 1 1
Skin Burning Sensation 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 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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