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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 6373
No Known Device Problem 4564
Impedance issue 1652
Temperature issue 1544
Migration of device or device component 1352
Communication or transmission issue 1173
Use of Device Issue 941
No device output 829
High impedance 682
Therapy delivered to incorrect body area 670
Charging issue 481
Low impedance 424
Device inoperable 398
Fracture 330
Unintended movement 306
No Information 284
Failure to charge 276
Disconnection 263
Inappropriate shock 229
Device displays error message 188
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 50
Delayed charge time 46
Kinked 42
Low battery 41
Malposition of device 40
Detachment of device component 34
Battery issue 33
Self-activation or keying 32
Difficult to insert 28
Output issue 26
Sticking 26
Failure to deliver energy 26
Premature end-of-life indicator 25
Replace 24
Fluid leak 21
Electro-magnetic interference (EMI) 20
Premature discharge of battery 19
Intermittent continuity 19
Improper or incorrect procedure or method 19
Detachment of device or device component 18
Lead(s), breakage of 16
Connection issue 16
Unknown (for use when the device problem is not known) 16
Failure to interrogate 15
Size incorrect for patient 15
Dislodged or dislocated 14
Bent 14
Cut in material 13
Implant, reprogramming of 13
Device remains activated 12
Difficult to remove 11
Wire(s), breakage of 11
Device handling issue 10
Unintended collision 10
Overheating of device or device component 10
Low battery impedance 10
Unstable 10
Device, or device fragments remain in patient 8
Difficult to position 8
Material separation 8
Out-of-box failure 7
Shock, electrical 7
Positioning Issue 7
Improper device output 7
Corrosion 7
Material integrity issue 7
Output above specifications 7
Difficult to open or close 7
Disinfection or Sterilization Issue at User Location 6
Material frayed 6
Expulsion 6
High battery impedance 5
Leak 5
Failure to conduct 5
Implant, removal of 5
Torn material 5
Other (for use when an appropriate device code cannot be identified) 5
Unexpected therapeutic results 5
Energy output to patient tissue incorrect 5
Tears, rips, holes in device, device material 4
Electromagnetic compatibility issue 4
Cardiac enzyme evaluation, erroneous 4
Arcing at electrodes 4
Device or device fragments location unknown 4
Malfunction 4
Material fragmentation 4
Unit inactivated 4
Device or device component damaged by another device 4
Telemetry discrepancy 3
Fitting problem 3
Material deformation 3
Loose or intermittent connection 3
Moisture or humidity problem 3
Total Device Problems 24630

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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