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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intestinal stimulator
Product CodeLNQ
Device Class Humanitarian Device Exemption

Device Problems
Inappropriate shock 131
Device operates differently than expected 120
No Known Device Problem 68
No Information 54
Explanted 54
Unknown (for use when the device problem is not known) 49
High impedance 45
Migration of device or device component 44
Electro-magnetic interference (EMI) 29
Premature discharge of battery 28
Other (for use when an appropriate device code cannot be identified) 21
Break 19
Replace 19
Material perforation 17
Implant, repositioning of 16
Implant, reprogramming of 14
Impedance issue 14
Device remains implanted 12
Malfunction 11
Low battery 11
Battery issue 10
Electro-magnetic interference (EMI), compatibility/incompatibility 10
Unintended collision 9
Electromagnetic compatibility issue 9
Pocket stimulation 8
Fracture 8
Intermittent continuity 8
Communication or transmission issue 8
Low impedance 7
Failure to deliver energy 7
Malposition of device 7
Electronic property issue 6
Material erosion 6
Shock, electrical 6
Failure to interrogate 5
Shipping damage or problem 5
Wire(s), breakage of 5
Device inoperable 5
Dislodged or dislocated 5
Unstable 4
Energy output to patient tissue incorrect 4
Detachment of device component 3
Lead(s), breakage of 3
Connection issue 3
Device or device fragments location unknown 3
Twisting 3
Therapy delivered to incorrect body area 3
Device stops intermittently 3
Shelf life exceeded 2
Unit inactivated 2
Unexpected therapeutic results 2
Tipover 2
Defective component 2
Implant, removal of 2
Looping 2
Loose or intermittent connection 2
Overheating of device or device component 2
Crack 2
Disconnection 2
Dislodged 2
Human-Device Interface Issue 2
Positioning Issue 2
Unintended movement 1
Material deformation 1
Material twisted 1
No code available 1
Foreign material present in device 1
Suspect EMI 1
Battery impedance issue 1
Coiled 1
Component(s), broken 1
Failure to Adhere or Bond 1
Elective replacement 1
Difficult to position 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Repair 1
Loose 1
Device maintenance issue 1
Kinked 1
Vibration 1
Residue after decontamination 1
Device displays error message 1
Loss of Data 1
Intermittent shock 1
Material separation 1
Stretched 1
Telemetry discrepancy 1
Size incorrect for patient 1
Steering wire problem 1
Total Device Problems 995

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 0 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Oct-29-2009

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