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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
A&E
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 6
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 5
DIAG CORP.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
EUROPEAN CUSTOM MANUFACTURING BV
  SUBSTANTIALLY EQUIVALENT 1
HARMAC MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 25
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 4
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ZYNERGY CARDIOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to pace or properly pace 85
Fluid leak 15
Break 14
Fracture 12
No code available 9
Inflation issue 7
Connection issue 6
Device, or device fragments remain in patient 4
Detachment of device component 4
Deflation issue 3
Disconnection 3
Replace 3
Material rupture 3
Wire(s), breakage of 3
Other (for use when an appropriate device code cannot be identified) 3
Material perforation 3
Material integrity issue 3
No Known Device Problem 2
Unknown (for use when the device problem is not known) 2
Tip breakage 2
Oversensing 2
Fitting problem 2
Device operates differently than expected 2
Difficult to insert 2
High impedance 2
Balloon rupture 2
Balloon burst 1
Bent 1
Measurements, inaccurate 1
Air leak 1
Failure to Adhere or Bond 1
Crack 1
Circuit Failure 1
Dislodged 1
Electrical issue 1
False reading from device non-compliance 1
Material fragmentation 1
Foreign material 1
Hole in material 1
Performance 1
Unable to obtain readings 1
Kinked 1
Leak 1
Migration of device or device component 1
Needle, separation 1
Occlusion within device 1
Failure to sense 1
Material separation 1
Source, detachment from 1
Sterility 1
Sticking 1
Dislodged or dislocated 1
Foreign material present in device 1
Deployment issue 1
High Readings 1
Physical resistance 1
Device or device fragments location unknown 1
Ambient noise issue 1
Capturing issue 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Low impedance 1
No pacing 1
Total Device Problems 235

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

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Jun-24-2009
2 Arrow International Inc II Sep-16-2008
3 European Custom Manufacturing B.V. II Feb-15-2012
4 Heart Sync, Inc II May-30-2013
5 Medtronic Inc III Apr-14-2009
6 Medtronic Inc., Cardiac Rhythm and Heart Failure II Sep-19-2016
7 Oscor, Inc. II Oct-29-2012

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