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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
Device operates differently than expected 182
Inappropriate shock 149
No Known Device Problem 96
Migration of device or device component 60
High impedance 58
Explanted 54
No Information 54
Unknown (for use when the device problem is not known) 49
Electro-magnetic interference (EMI) 36
Premature discharge of battery 35
Break 28
Other (for use when an appropriate device code cannot be identified) 21
Electromagnetic compatibility issue 20
Replace 19
Failure to deliver energy 19
Material perforation 17
Battery issue 17
Implant, repositioning of 16
Low battery 16
Unintended collision 15
Implant, reprogramming of 14
Impedance issue 14
Pocket stimulation 13
Device remains implanted 12
Intermittent continuity 12
Malposition of device 11
Malfunction 11
Communication or transmission issue 10
Electro-magnetic interference (EMI), compatibility/incompatibility 10
Low impedance 8
Fracture 8
Failure to interrogate 7
Therapy delivered to incorrect body area 7
Unstable 7
Material erosion 6
Shock, electrical 6
Electronic property issue 6
Dislodged or dislocated 5
Device inoperable 5
Shipping damage or problem 5
Wire(s), breakage of 5
Device or device fragments location unknown 4
Energy output to patient tissue incorrect 4
Connection issue 4
Human-Device Interface Issue 3
Disconnection 3
Detachment of device component 3
Lead(s), breakage of 3
Overheating of device or device component 3
Device displays error message 3
Twisting 3
Shelf life exceeded 3
Device stops intermittently 3
Unit inactivated 2
Unexpected therapeutic results 2
Tipover 2
Defective component 2
Implant, removal of 2
Difficult to remove 2
Looping 2
Loose or intermittent connection 2
Crack 2
Dislodged 2
Loss of Data 2
Foreign material present in device 2
Positioning Issue 2
Unintended movement 1
No code available 1
Material deformation 1
Material twisted 1
Environmental control or utility issue 1
Elective replacement 1
Failure to Adhere or Bond 1
Coiled 1
Component(s), broken 1
Loose 1
Device maintenance issue 1
Kinked 1
Repair 1
Device, or device fragments remain in patient 1
Difficult to position 1
Residue after decontamination 1
Intermittent shock 1
Suspect EMI 1
Battery impedance issue 1
Vibration 1
Electro-static discharge 1
Stretched 1
Telemetry discrepancy 1
Size incorrect for patient 1
Steering wire problem 1
Material separation 1
Total Device Problems 1234

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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