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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
  1.  K140972  UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR ...
  2.  K161249  Streamline 6495 Bipolar Temporary Myocardial Pacin ...
  3.  K171253  Streamline 6491 Unipolar Pediatric Temporary Pacin ...
  4.  K190716  Streamline 6491 Unipolar Pediatric Temporary Pacin ...
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K140972  UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR ...
  2.  K161249  Streamline 6495 Bipolar Temporary Myocardial Pacin ...
  3.  K171253  Streamline 6491 Unipolar Pediatric Temporary Pacin ...
  4.  K190716  Streamline 6491 Unipolar Pediatric Temporary Pacin ...
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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