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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 211
Inappropriate shock 154
No Known Device Problem 107
Migration of device or device component 64
High impedance 62
Explanted 54
No Information 54
Unknown (for use when the device problem is not known) 49
Electro-magnetic interference (EMI) 41
Premature discharge of battery 36
Break 33
Electromagnetic compatibility issue 25
Low battery 24
Failure to deliver energy 24
Other (for use when an appropriate device code cannot be identified) 21
Unintended collision 19
Replace 19
Battery issue 18
Material perforation 17
Impedance issue 16
Implant, repositioning of 16
Pocket stimulation 15
Implant, reprogramming of 14
Malposition of device 12
Device remains implanted 12
Intermittent continuity 12
Malfunction 11
Therapy delivered to incorrect body area 10
Communication or transmission issue 10
Electro-magnetic interference (EMI), compatibility/incompatibility 10
Unstable 9
Low impedance 8
Fracture 8
Failure to interrogate 7
Overheating of device or device component 7
Material erosion 6
Shock, electrical 6
Electronic property issue 6
Device inoperable 5
Shipping damage or problem 5
Dislodged or dislocated 5
Wire(s), breakage of 5
Disconnection 4
Device or device fragments location unknown 4
Connection issue 4
Energy output to patient tissue incorrect 4
Human-Device Interface Issue 3
Device stops intermittently 3
Twisting 3
Device displays error message 3
Shelf life exceeded 3
Foreign material present in device 3
Lead(s), breakage of 3
Detachment of device component 3
Material deformation 2
Dislodged 2
Unit inactivated 2
Implant, removal of 2
Crack 2
Loose or intermittent connection 2
Positioning Issue 2
Looping 2
Tipover 2
Defective component 2
Loss of Data 2
Unexpected therapeutic results 2
Difficult to remove 2
Material twisted 1
Device, or device fragments remain in patient 1
Vibration 1
Electro-static discharge 1
Failure to Adhere or Bond 1
Suspect EMI 1
Intermittent shock 1
No code available 1
Elective replacement 1
Residue after decontamination 1
Coiled 1
Ambient noise issue 1
Entrapment of device or device component 1
Battery impedance issue 1
Kinked 1
Incorrect display 1
Difficult to position 1
Stretched 1
Component(s), broken 1
Material separation 1
Telemetry discrepancy 1
Repair 1
Environmental control or utility issue 1
Steering wire problem 1
Device maintenance issue 1
Unintended movement 1
Loose 1
Size incorrect for patient 1
Total Device Problems 1341

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0 0
Class III 0 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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