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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 232
Inappropriate shock 162
No Known Device Problem 122
High impedance 67
Migration of device or device component 66
Explanted 54
No Information 54
Unknown (for use when the device problem is not known) 49
Electro-magnetic interference (EMI) 43
Premature discharge of battery 38
Break 36
Electromagnetic compatibility issue 28
Low battery 26
Failure to deliver energy 25
Unintended collision 22
Other (for use when an appropriate device code cannot be identified) 21
Battery issue 21
Replace 19
Impedance issue 18
Material perforation 17
Implant, repositioning of 16
Pocket stimulation 16
Implant, reprogramming of 14
Unstable 13
Malposition of device 12
Therapy delivered to incorrect body area 12
Device remains implanted 12
Intermittent continuity 12
Communication or transmission issue 11
Malfunction 11
Electro-magnetic interference (EMI), compatibility/incompatibility 10
Low impedance 8
Fracture 8
Failure to interrogate 8
Overheating of device or device component 7
Shock, electrical 6
Material erosion 6
Device or device fragments location unknown 6
Positioning Issue 6
Electronic property issue 6
Foreign material present in device 5
Dislodged or dislocated 5
Device inoperable 5
Shipping damage or problem 5
Wire(s), breakage of 5
Energy output to patient tissue incorrect 4
Disconnection 4
Connection issue 4
Device displays error message 3
Human-Device Interface Issue 3
Detachment of device component 3
Lead(s), breakage of 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
Looping 2
Loose or intermittent connection 2
Difficult to remove 2
Crack 2
Dislodged 2
Material deformation 2
Loss of Data 2
Material twisted 1
Unintended movement 1
Environmental control or utility issue 1
No code available 1
Incorrect display 1
Elective replacement 1
Entrapment of device or device component 1
Degraded 1
Failure to Adhere or Bond 1
Coiled 1
Component(s), broken 1
Repair 1
Device, or device fragments remain in patient 1
Difficult to position 1
Loose 1
Device maintenance issue 1
Kinked 1
Residue after decontamination 1
Intermittent shock 1
Suspect EMI 1
Ambient noise issue 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 1431

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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