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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, pacemaker, temporary
Regulation Description Cardiovascular permanent or temporary pacemaker electrode.
Product CodeLDF
Regulation Number 870.3680
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Pacing Problem 100
Adverse Event Without Identified Device or Use Problem 28
Break 26
Appropriate Term/Code Not Available 11
Detachment Of Device Component 10
Material Integrity Problem 9
Material Rupture 7
Failure to Capture 5
Over-Sensing 5
Inflation Problem 5
No Pacing 5
Connection Problem 5
Fracture 4
Detachment of Device or device Component 4
Insufficient Information 4
Fluid Leak 3
Leak / Splash 3
Device Operates Differently Than Expected 3
Human-Device Interface Problem 3
Tear, Rip or Hole in Device Packaging 3
Device Dislodged or Dislocated 3
Deflation Problem 2
Balloon 2
Electrical /Electronic Property Problem 2
High impedance 2
Migration or Expulsion of Device 2
Fitting Problem 2
Accessory Incompatible 2
High Capture Threshold 2
Nonstandard device 2
Malposition of device 2
Ambient Noise Problem 2
Disconnection 2
Entrapment of Device 2
Difficult to Insert 1
Loose or Intermittent Connection 1
No Device Output 1
Failure to Unfold or Unwrap 1
Inadequate User Interface 1
Material Fragmentation 1
Material Separation 1
Incomplete or Missing Packaging 1
Device Contamination with Chemical or Other Material 1
Sticking 1
Pacing Inadequately 1
Failure to Sense 1
Physical Resistance 1
Gas Leak 1
Bent 1
Device Sensing Problem 1
Missing Information 1
Improper or Incorrect Procedure or Method 1
Low impedance 1
Failure To Adhere Or Bond 1
Unraveled Material 1
Circuit Failure 1
Incorrect Measurement 1
Device Difficult to Setup or Prepare 1
Component Missing 1
Capturing Problem 1
Activation, Positioning or Separation Problem 1
Catheter 1
Material Split, Cut or Torn 1
Electrode 1
Total Device Problems 302

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Jul-29-2019
2 Medtronic Inc., Cardiac Rhythm and Heart Failure II Sep-19-2016
3 Oscor, Inc. I Nov-08-2018

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