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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, spinal-cord, implanted (pain relief)
Regulation Description Implanted spinal cord stimulator for pain relief.
Product CodeGZB
Regulation Number 882.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED NEUROMODULATION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 25
ANULEX TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 4
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 61
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device operates differently than expected 6447
No Known Device Problem 5198
Impedance issue 1679
Temperature issue 1544
Migration of device or device component 1376
Communication or transmission issue 1193
Use of Device Issue 945
High impedance 836
No device output 833
Therapy delivered to incorrect body area 687
Charging issue 522
Low impedance 454
Device inoperable 401
Fracture 347
Unintended movement 306
No Information 285
Failure to charge 276
Disconnection 271
Inappropriate shock 236
Device displays error message 211
Difficult to advance 141
Device stops intermittently 137
Nonstandard device or device component 125
Failure to advance 83
Explanted 78
Break 71
Low battery 60
Device remains implanted 56
Delayed charge time 55
Battery issue 52
Pocket stimulation 52
Failure to deliver energy 48
Malposition of device 45
Kinked 44
Detachment of device component 34
Improper or incorrect procedure or method 33
Self-activation or keying 32
Intermittent continuity 28
Difficult to insert 28
Unintended collision 26
Sticking 26
Output issue 26
Premature end-of-life indicator 25
Replace 24
Fluid leak 24
Electro-magnetic interference (EMI) 22
Failure to interrogate 22
Connection issue 21
Overheating of device or device component 19
Premature discharge of battery 19
Detachment of device or device component 18
Lead(s), breakage of 16
Cut in material 16
Unknown (for use when the device problem is not known) 16
Size incorrect for patient 15
Unstable 14
Bent 14
Dislodged or dislocated 14
Implant, reprogramming of 13
Device remains activated 12
Material integrity issue 12
Difficult to remove 11
Wire(s), breakage of 11
Low battery impedance 10
Improper device output 10
Positioning Issue 10
Device handling issue 10
Material frayed 9
Difficult to position 8
Device, or device fragments remain in patient 8
Material separation 8
Unexpected therapeutic results 7
Out-of-box failure 7
Output above specifications 7
Energy output to patient tissue incorrect 7
Corrosion 7
Shock, electrical 7
Material deformation 7
Difficult to open or close 7
Disinfection or Sterilization Issue at User Location 6
Electromagnetic compatibility issue 6
Expulsion 6
High battery impedance 5
Torn material 5
Failure to conduct 5
Implant, removal of 5
Other (for use when an appropriate device code cannot be identified) 5
Unit inactivated 4
Tears, rips, holes in device, device material 4
Arcing at electrodes 4
Cardiac enzyme evaluation, erroneous 4
Malfunction 4
Device or device fragments location unknown 4
Material fragmentation 4
Leak 4
Device or device component damaged by another device 4
Battery impedance issue 3
Inadequate instructions for non-healthcare professional 3
Operating system becomes non-functional 3
Material twisted 3
Total Device Problems 25905

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 1 0 1 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Neuromodulation Systems, Inc II Apr-21-2010
2 Medtronic Neuromodulation II Sep-18-2008
3 St. Jude Medical, Inc. II Sep-29-2014

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