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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 6421
No Known Device Problem 4639
Impedance issue 1655
Temperature issue 1544
Migration of device or device component 1369
Communication or transmission issue 1188
Use of Device Issue 945
No device output 831
High impedance 703
Therapy delivered to incorrect body area 680
Charging issue 512
Low impedance 428
Device inoperable 400
Fracture 333
Unintended movement 306
No Information 285
Failure to charge 276
Disconnection 265
Inappropriate shock 234
Device displays error message 205
Difficult to advance 141
Device stops intermittently 132
Nonstandard device or device component 125
Failure to advance 83
Explanted 78
Break 63
Low battery 57
Device remains implanted 56
Delayed charge time 52
Pocket stimulation 52
Battery issue 45
Malposition of device 43
Kinked 42
Failure to deliver energy 38
Detachment of device component 33
Self-activation or keying 32
Improper or incorrect procedure or method 31
Difficult to insert 28
Sticking 26
Output issue 26
Premature end-of-life indicator 25
Intermittent continuity 25
Replace 24
Electro-magnetic interference (EMI) 22
Fluid leak 21
Failure to interrogate 21
Unintended collision 19
Premature discharge of battery 19
Connection issue 19
Detachment of device or device component 18
Overheating of device or device component 18
Lead(s), breakage of 16
Unknown (for use when the device problem is not known) 16
Size incorrect for patient 15
Bent 14
Dislodged or dislocated 14
Implant, reprogramming of 13
Cut in material 13
Device remains activated 12
Difficult to remove 11
Wire(s), breakage of 11
Material integrity issue 11
Low battery impedance 10
Positioning Issue 10
Device handling issue 10
Unstable 10
Improper device output 9
Device, or device fragments remain in patient 8
Material separation 8
Difficult to position 8
Output above specifications 7
Corrosion 7
Shock, electrical 7
Unexpected therapeutic results 7
Out-of-box failure 7
Difficult to open or close 7
Disinfection or Sterilization Issue at User Location 6
Expulsion 6
Material deformation 6
Energy output to patient tissue incorrect 6
Material frayed 6
Failure to conduct 5
Other (for use when an appropriate device code cannot be identified) 5
Implant, removal of 5
High battery impedance 5
Electromagnetic compatibility issue 5
Torn material 5
Device or device component damaged by another device 4
Cardiac enzyme evaluation, erroneous 4
Arcing at electrodes 4
Malfunction 4
Device or device fragments location unknown 4
Tears, rips, holes in device, device material 4
Unit inactivated 4
Material fragmentation 4
Leak 4
Loose or intermittent connection 3
Mechanical issue 3
Material erosion 3
Electrode(s), fracture of 3
Total Device Problems 25002

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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