• 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


Premarket Reviews
ManufacturerDecision
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 41 41
2016 20 20
2017 15 15
2018 29 29
2019 34 34
2020 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 55 55
Material Integrity Problem 17 17
High impedance 17 17
Over-Sensing 11 11
Signal Artifact/Noise 11 11
High Capture Threshold 10 10
Failure to Capture 9 9
Impedance Problem 9 9
Fracture 8 8
Connection Problem 7 7
Low impedance 6 6
Device Dislodged or Dislocated 5 5
Capturing Problem 4 4
Insufficient Information 4 4
Mechanical Problem 4 4
Ambient Noise Problem 4 4
Device Operates Differently Than Expected 3 3
Human-Device Interface Problem 2 2
Break 2 2
Shelf Life Exceeded 2 2
Patient Lead 2 2
Electrical /Electronic Property Problem 2 2
Pacing Problem 2 2
Pocket Stimulation 2 2
Intermittent Capture 1 1
Difficult or Delayed Positioning 1 1
High Sensing Threshold 1 1
Material Deformation 1 1
Device Markings/Labelling Problem 1 1
Device Sensing Problem 1 1
Electronic Property Issue 1 1
Unstable Capture Threshold 1 1
Device Fell 1 1
Under-Sensing 1 1
Component(s), broken 1 1
Difficult To Position 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 58 58
Unspecified Infection 44 44
No Consequences Or Impact To Patient 22 22
Erosion 6 6
Sepsis 4 4
Therapeutic Response, Decreased 4 4
Dizziness 3 3
Chest Pain 3 3
Death 3 3
Syncope 3 3
No Information 3 3
No Code Available 2 2
Complaint, Ill-Defined 2 2
Cardiac Perforation 2 2
Muscle Stimulation 2 2
Therapeutic Response, Increased 2 2
Undesired Nerve Stimulation 2 2
Pain 2 2
Pocket Erosion 2 2
Wound Dehiscence 2 2
Perforation 2 2
Palpitations 1 1
Dyspnea 1 1
Fever 1 1
Hematoma 1 1
Pericardial Effusion 1 1
Ventricular Fibrillation 1 1
Burning Sensation 1 1
Discomfort 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Head Injury 1 1
Necrosis 1 1
No Patient Involvement 1 1

-
-