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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 6372
No Known Device Problem 4564
Impedance issue 1651
Temperature issue 1544
Migration of device or device component 1351
Communication or transmission issue 1171
Use of Device Issue 941
No device output 828
High impedance 681
Therapy delivered to incorrect body area 670
Charging issue 480
Low impedance 424
Device inoperable 398
Fracture 330
Unintended movement 306
No Information 284
Failure to charge 276
Disconnection 263
Inappropriate shock 227
Device displays error message 187
Difficult to advance 141
Device stops intermittently 132
Nonstandard device or device component 125
Failure to advance 83
Explanted 78
Break 62
Device remains implanted 56
Pocket stimulation 49
Delayed charge time 46
Kinked 42
Low battery 40
Malposition of device 40
Detachment of device component 34
Battery issue 33
Self-activation or keying 32
Difficult to insert 28
Sticking 26
Output issue 26
Premature end-of-life indicator 25
Failure to deliver energy 24
Replace 24
Fluid leak 21
Electro-magnetic interference (EMI) 20
Premature discharge of battery 19
Intermittent continuity 18
Improper or incorrect procedure or method 18
Detachment of device or device component 18
Connection issue 16
Unknown (for use when the device problem is not known) 16
Lead(s), breakage of 16
Size incorrect for patient 15
Bent 14
Dislodged or dislocated 14
Failure to interrogate 13
Cut in material 13
Implant, reprogramming of 13
Device remains activated 12
Difficult to remove 11
Wire(s), breakage of 11
Unstable 10
Overheating of device or device component 10
Low battery impedance 10
Device handling issue 10
Unintended collision 9
Device, or device fragments remain in patient 8
Material separation 8
Difficult to position 8
Corrosion 7
Shock, electrical 7
Output above specifications 7
Out-of-box failure 7
Positioning Issue 7
Material integrity issue 7
Improper device output 7
Difficult to open or close 7
Disinfection or Sterilization Issue at User Location 6
Expulsion 6
Material frayed 6
Leak 5
Failure to conduct 5
Energy output to patient tissue incorrect 5
Implant, removal of 5
Other (for use when an appropriate device code cannot be identified) 5
Unexpected therapeutic results 5
High battery impedance 5
Torn material 5
Device or device component damaged by another device 4
Electromagnetic compatibility issue 4
Tears, rips, holes in device, device material 4
Unit inactivated 4
Arcing at electrodes 4
Cardiac enzyme evaluation, erroneous 4
Malfunction 4
Device or device fragments location unknown 4
Material fragmentation 4
Loose or intermittent connection 3
Mechanical issue 3
Electrode(s), fracture of 3
Material erosion 3
Computer software issue 3
Total Device Problems 24610

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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