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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 336
No Known Device Problem 196
Inappropriate shock 193
Migration of device or device component 98
High impedance 96
Explanted 54
No Information 54
Electro-magnetic interference (EMI) 52
Break 51
Premature discharge of battery 49
Unknown (for use when the device problem is not known) 49
Low battery 47
Electromagnetic compatibility issue 43
Failure to deliver energy 34
Unintended collision 32
Battery issue 25
Impedance issue 25
Unstable 24
Pocket stimulation 22
Other (for use when an appropriate device code cannot be identified) 21
Malposition of device 21
Replace 19
Material perforation 17
Implant, repositioning of 16
Intermittent continuity 16
Communication or transmission issue 16
Implant, reprogramming of 14
Therapy delivered to incorrect body area 13
Failure to interrogate 13
Device remains implanted 12
Positioning Issue 12
Overheating of device or device component 11
Malfunction 11
Electro-magnetic interference (EMI), compatibility/incompatibility 10
Device displays error message 10
Device or device fragments location unknown 9
Low impedance 9
Fracture 8
Disconnection 8
Shipping damage or problem 7
Foreign material present in device 7
Human-Device Interface Issue 7
Connection issue 7
Material deformation 7
Electronic property issue 6
Shock, electrical 6
Material erosion 6
Device inoperable 5
Shelf life exceeded 5
Wire(s), breakage of 5
Dislodged or dislocated 5
Unexpected therapeutic results 4
Energy output to patient tissue incorrect 4
Entrapment of device or device component 4
Detachment of device component 3
Lead(s), breakage of 3
Twisting 3
Device stops intermittently 3
Unit inactivated 2
Difficult to remove 2
Tipover 2
Vibration 2
Defective component 2
Implant, removal of 2
Looping 2
Loose or intermittent connection 2
No device output 2
Crack 2
Degraded 2
Dislodged 2
Environmental control or utility issue 2
Loss of Data 2
Suspect EMI 1
Ambient noise issue 1
Battery impedance issue 1
Material twisted 1
No code available 1
Unauthorized access to computer system 1
Unintended movement 1
Incorrect display 1
Elective replacement 1
Computer software issue 1
Bent 1
Coiled 1
Component(s), broken 1
Kinked 1
Unable to obtain readings 1
Difficult to position 1
Difficult to Program or Calibrate 1
Loose 1
Device maintenance issue 1
Failure to Adhere or Bond 1
Electro-static discharge 1
Intermittent shock 1
Residue after decontamination 1
Repair 1
Device, or device fragments remain in patient 1
Material separation 1
Stretched 1
Telemetry discrepancy 1
Total Device Problems 1899

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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