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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 123
Device operates differently than expected 105
No Known Device Problem 63
Explanted 54
No Information 54
Unknown (for use when the device problem is not known) 49
High impedance 42
Migration of device or device component 40
Electro-magnetic interference (EMI) 29
Premature discharge of battery 27
Other (for use when an appropriate device code cannot be identified) 21
Replace 19
Material perforation 17
Break 17
Implant, repositioning of 16
Implant, reprogramming of 14
Device remains implanted 12
Malfunction 11
Impedance issue 11
Electro-magnetic interference (EMI), compatibility/incompatibility 10
Battery issue 10
Electromagnetic compatibility issue 9
Low battery 9
Intermittent continuity 8
Communication or transmission issue 8
Fracture 8
Pocket stimulation 7
Low impedance 7
Malposition of device 7
Unintended collision 7
Shock, electrical 6
Failure to deliver energy 6
Material erosion 6
Electronic property issue 6
Device inoperable 5
Failure to interrogate 5
Shipping damage or problem 5
Dislodged or dislocated 5
Wire(s), breakage of 5
Energy output to patient tissue incorrect 4
Unstable 3
Device stops intermittently 3
Connection issue 3
Twisting 3
Lead(s), breakage of 3
Detachment of device component 3
Dislodged 2
Therapy delivered to incorrect body area 2
Unit inactivated 2
Disconnection 2
Loose or intermittent connection 2
Positioning Issue 2
Device or device fragments location unknown 2
Crack 2
Overheating of device or device component 2
Implant, removal of 2
Shelf life exceeded 2
Looping 2
Tipover 2
Unexpected therapeutic results 2
Defective component 2
Human-Device Interface Issue 2
Material twisted 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Vibration 1
Failure to Adhere or Bond 1
Loss of Data 1
Suspect EMI 1
Intermittent shock 1
No code available 1
Residue after decontamination 1
Device displays error message 1
Elective replacement 1
Coiled 1
Stretched 1
Difficult to position 1
Component(s), broken 1
Kinked 1
Battery impedance issue 1
Repair 1
Material separation 1
Steering wire problem 1
Telemetry discrepancy 1
Size incorrect for patient 1
Material deformation 1
Unintended movement 1
Loose 1
Device maintenance issue 1
Total Device Problems 944

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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