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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cable, electrode
Regulation Description Electrode cable.
Product CodeIKD
Regulation Number 890.1175
Device Class 2


Premarket Reviews
ManufacturerDecision
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Connection issue 54
Break 12
Burn of device or device component 6
Cable break 5
Failure to pace or properly pace 3
Device operates differently than expected 3
No Known Device Problem 2
Spark 2
Misconnection 2
Capturing issue 1
Detachment of device or device component 1
Not Applicable 1
No pacing 1
Replace 1
Use of Device Issue 1
Invalid sensing 1
Electrical wires, defective 1
Device Issue 1
High sensing threshold 1
Low sensing threshold 1
Failure to capture 1
Disconnection 1
Electrical issue 1
Failure to deliver energy 1
Fracture 1
Total Device Problems 105

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 1
Class II 0 0 1 0 2 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Apr-15-2016
2 Oscor, Inc. I Apr-10-2017
3 St. Jude Medical II Aug-05-2011
4 Sterilmed Inc II Jan-13-2009
5 Vermed, Inc. II May-04-2011

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