• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device intestinal stimulator
Product CodeLNQ
Device Class Humanitarian Device Exemption

Device Problems
Device operates differently than expected 245
Inappropriate shock 163
No Known Device Problem 134
High impedance 73
Migration of device or device component 69
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 39
Break 39
Low battery 29
Electromagnetic compatibility issue 27
Failure to deliver energy 25
Unintended collision 23
Battery issue 22
Other (for use when an appropriate device code cannot be identified) 21
Impedance issue 20
Replace 19
Unstable 17
Material perforation 17
Pocket stimulation 17
Implant, repositioning of 16
Implant, reprogramming of 14
Malposition of device 14
Device remains implanted 12
Intermittent continuity 12
Therapy delivered to incorrect body area 11
Malfunction 11
Communication or transmission issue 11
Electro-magnetic interference (EMI), compatibility/incompatibility 10
Low impedance 8
Overheating of device or device component 8
Fracture 8
Failure to interrogate 8
Positioning Issue 8
Device or device fragments location unknown 7
Material erosion 6
Shock, electrical 6
Foreign material present in device 6
Electronic property issue 6
Dislodged or dislocated 5
Human-Device Interface Issue 5
Connection issue 5
Wire(s), breakage of 5
Device inoperable 5
Shipping damage or problem 5
Device displays error message 4
Energy output to patient tissue incorrect 4
Disconnection 4
Detachment of device component 3
Lead(s), breakage of 3
Shelf life exceeded 3
Device stops intermittently 3
Twisting 3
Material deformation 3
Environmental control or utility issue 2
Loss of Data 2
Unit inactivated 2
Unexpected therapeutic results 2
Difficult to remove 2
Tipover 2
Defective component 2
Implant, removal of 2
Looping 2
Loose or intermittent connection 2
Crack 2
Dislodged 2
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
Loose 1
Device maintenance issue 1
Kinked 1
Device, or device fragments remain in patient 1
Difficult to position 1
Residue after decontamination 1
Intermittent shock 1
Repair 1
Material separation 1
Size incorrect for patient 1
Steering wire problem 1
Vibration 1
Electro-static discharge 1
Stretched 1
Telemetry discrepancy 1
Suspect EMI 1
Ambient noise issue 1
Battery impedance issue 1
Material twisted 1
Unintended movement 1
No code available 1
Total Device Problems 1493

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

-
-