Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device pacemaker lead adaptor
Regulation Description Pacemaker lead adaptor.
Product CodeDTD
Regulation Number 870.3620
Device Class 2

MDR Year MDR Reports MDR Events
2021 23 23
2022 25 26
2023 28 29
2024 35 35
2025 32 32
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 73 73
Over-Sensing 12 12
High Capture Threshold 11 11
Signal Artifact/Noise 7 7
High impedance 7 7
Failure to Capture 6 6
Low impedance 6 6
Ambient Noise Problem 5 5
Device Sensing Problem 5 5
Insufficient Information 4 4
Degraded 4 4
Capturing Problem 4 4
Break 3 3
Use of Device Problem 3 3
Pacing Problem 3 3
Appropriate Term/Code Not Available 3 3
Off-Label Use 2 2
No Apparent Adverse Event 2 2
Under-Sensing 2 2
Connection Problem 2 2
Device Alarm System 1 2
Failure to Sense 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Battery Problem 1 1
Impedance Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Fracture 1 1
Pocket Stimulation 1 1
High Sensing Threshold 1 1
Premature Discharge of Battery 1 2
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 58 58
No Clinical Signs, Symptoms or Conditions 58 60
Insufficient Information 10 10
Failure of Implant 6 6
Discomfort 5 5
Fever 4 4
Erythema 4 4
Swelling/ Edema 4 4
Endocarditis 4 4
Pocket Erosion 4 4
Sepsis 3 3
Dizziness 3 3
Purulent Discharge 3 3
Bacterial Infection 3 3
Wound Dehiscence 2 2
Arrhythmia 2 2
Pain 2 2
Bradycardia 2 2
Fluid Discharge 2 2
Erosion 2 2
Hypersensitivity/Allergic reaction 1 1
Presyncope 1 1
Hematoma 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Skin Erosion 1 1
Chills 1 1
Cardiac Perforation 1 1
Congenital Defect/Deformity 1 1
Heart Failure/Congestive Heart Failure 1 1
Heart Block 1 1
Respiratory Failure 1 1
Device Embedded In Tissue or Plaque 1 1

-
-