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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 141
Device operates differently than expected 136
No Known Device Problem 81
No Information 54
Explanted 54
High impedance 49
Unknown (for use when the device problem is not known) 49
Migration of device or device component 48
Electro-magnetic interference (EMI) 31
Premature discharge of battery 29
Break 23
Other (for use when an appropriate device code cannot be identified) 21
Replace 19
Material perforation 17
Implant, repositioning of 16
Implant, reprogramming of 14
Impedance issue 14
Electromagnetic compatibility issue 14
Battery issue 12
Low battery 12
Unintended collision 12
Device remains implanted 12
Pocket stimulation 11
Malfunction 11
Electro-magnetic interference (EMI), compatibility/incompatibility 10
Communication or transmission issue 10
Malposition of device 9
Fracture 8
Intermittent continuity 8
Failure to deliver energy 7
Failure to interrogate 7
Low impedance 7
Material erosion 6
Shock, electrical 6
Electronic property issue 6
Dislodged or dislocated 5
Wire(s), breakage of 5
Shipping damage or problem 5
Device inoperable 5
Unstable 5
Therapy delivered to incorrect body area 4
Energy output to patient tissue incorrect 4
Detachment of device component 3
Lead(s), breakage of 3
Shelf life exceeded 3
Device stops intermittently 3
Twisting 3
Device or device fragments location unknown 3
Connection issue 3
Foreign material present in device 2
Human-Device Interface Issue 2
Positioning Issue 2
Tipover 2
Defective component 2
Implant, removal of 2
Unit inactivated 2
Unexpected therapeutic results 2
Looping 2
Loose or intermittent connection 2
Overheating of device or device component 2
Crack 2
Disconnection 2
Dislodged 2
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
Electro-static discharge 1
Stretched 1
Telemetry discrepancy 1
Size incorrect for patient 1
Steering wire problem 1
Material separation 1
Residue after decontamination 1
Intermittent shock 1
Device displays error message 1
Unintended movement 1
Material deformation 1
Material twisted 1
Environmental control or utility issue 1
Loss of Data 1
Suspect EMI 1
Battery impedance issue 1
No code available 1
Total Device Problems 1075

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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