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
2019 34 34
2020 19 19
2021 23 23
2022 25 26
2023 28 29
2024 35 35
2025 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 93 93
Over-Sensing 18 18
High impedance 13 13
High Capture Threshold 13 13
Signal Artifact/Noise 11 11
Failure to Capture 8 8
Ambient Noise Problem 8 8
Low impedance 7 7
Insufficient Information 5 5
Impedance Problem 5 5
Device Sensing Problem 5 5
Break 4 4
Capturing Problem 4 4
Connection Problem 4 4
Fracture 4 4
Degraded 4 4
Appropriate Term/Code Not Available 3 3
Pacing Problem 3 3
Under-Sensing 3 3
Use of Device Problem 3 3
Detachment of Device or Device Component 2 2
Material Integrity Problem 2 2
Off-Label Use 2 2
Noise, Audible 2 2
Unstable Capture Threshold 1 1
Difficult or Delayed Positioning 1 1
Retraction Problem 1 1
Battery Problem 1 1
No Apparent Adverse Event 1 1
Material Separation 1 1
Intermittent Capture 1 1
Patient Device Interaction Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Sense 1 1
Device Fell 1 1
Device Alarm System 1 2
Pocket Stimulation 1 1
High Sensing Threshold 1 1
Loose or Intermittent Connection 1 1
Premature Discharge of Battery 1 2
Mechanical Jam 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 78 78
No Clinical Signs, Symptoms or Conditions 55 57
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 9 9
Erosion 7 7
Pocket Erosion 6 6
Sepsis 6 6
Failure of Implant 6 6
Discomfort 5 5
No Consequences Or Impact To Patient 5 5
Fever 4 4
Erythema 4 4
Swelling/ Edema 4 4
Endocarditis 4 4
Dizziness 3 3
Purulent Discharge 3 3
Wound Dehiscence 3 3
Hematoma 2 2
Pain 2 2
Bradycardia 2 2
Fluid Discharge 2 2
Therapeutic Response, Decreased 2 2
Bacterial Infection 2 2
Arrhythmia 2 2
No Information 1 1
Presyncope 1 1
Head Injury 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Erosion 1 1
Burning Sensation 1 1
Chills 1 1
Cardiac Perforation 1 1
Chest Pain 1 1
Skin Inflammation 1 1
Death 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

-
-