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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, intragastric for morbid obesity
Product CodeLTI
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
2 5 4 7 10 1 1

Device Problems
Explanted 2332
Leak 1801
Fluid leak 1717
No Known Device Problem 866
Slippage of device or device component 826
Device remains implanted 424
Migration of device or device component 140
Patient-device incompatibility 114
Displacement 60
Unknown (for use when the device problem is not known) 41
No code available 40
Inflation issue 39
Deflation issue 38
Material erosion 35
Implant, repositioning of 25
Break 24
Buckled material 20
Disconnection 20
Kinked 18
No Information 17
Device Issue 15
Detachment of device or device component 15
Other (for use when an appropriate device code cannot be identified) 15
Obstruction within device 13
Disengaged 13
Reflux within device 11
Device, removal of (non-implant) 11
Torn material 5
Not Applicable 5
Occlusion within device 4
Radiation leak 4
Device operates differently than expected 4
Detachment of device component 3
Extrusion 3
Infusion or flow issue 3
Difficult to insert 3
Retraction problem 2
Balloon leak(s) 2
Hole in material 2
Failure to deploy 2
Dislodged or dislocated 2
Positioning Issue 2
Device or device fragments location unknown 2
Rupture, cause unknown 1
Tube(s), defective 1
Blockage within device or device component 1
Device clogged 1
Difficult to flush 1
Invalid sensing 1
Component falling 1
Source, detachment from 1
Difficult to fold or unfold 1
Fracture 1
Failure to Adhere or Bond 1
Aspiration issue 1
Material perforation 1
Air leak 1
Implant, removal of 1
Unsealed device packaging 1
Difficult to position 1
Source, leak(s) from 1
Difficult to open or close 1
Visibility/palpability 1
Tubing, incorrect placement of 1
Measurement system incompatibility 1
Sticking 1
Port leak(s) 1
Malposition of device 1
Extrusion, impending 1
Implant extrusion 1
Balloon rupture 1
Material fragmentation 1
Total Device Problems 8767

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

Recalls
Manufacturer Recall Class Date Posted
1 Allergan II May-02-2011
2 Allergan II Nov-18-2010
3 Ethicon Endo-Surgery Inc II Nov-02-2010

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