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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 6331
No Known Device Problem 4554
Impedance issue 1649
Temperature issue 1542
Migration of device or device component 1333
Communication or transmission issue 1156
Use of Device Issue 940
No device output 828
High impedance 668
Therapy delivered to incorrect body area 666
Charging issue 460
Low impedance 423
Device inoperable 398
Fracture 329
Unintended movement 306
No Information 284
Failure to charge 276
Disconnection 261
Inappropriate shock 218
Device displays error message 176
Difficult to advance 141
Device stops intermittently 132
Nonstandard device or device component 125
Failure to advance 83
Explanted 78
Break 59
Device remains implanted 56
Pocket stimulation 48
Delayed charge time 44
Kinked 42
Malposition of device 35
Detachment of device component 33
Low battery 32
Self-activation or keying 32
Difficult to insert 28
Output issue 26
Sticking 26
Premature end-of-life indicator 25
Replace 24
Fluid leak 21
Battery issue 19
Premature discharge of battery 18
Detachment of device or device component 18
Electro-magnetic interference (EMI) 18
Lead(s), breakage of 16
Unknown (for use when the device problem is not known) 16
Size incorrect for patient 15
Dislodged or dislocated 14
Bent 13
Implant, reprogramming of 13
Cut in material 13
Device remains activated 12
Difficult to remove 11
Improper or incorrect procedure or method 11
Wire(s), breakage of 11
Device handling issue 10
Low battery impedance 10
Intermittent continuity 10
Connection issue 10
Device, or device fragments remain in patient 8
Difficult to position 8
Material separation 8
Out-of-box failure 7
Failure to deliver energy 7
Shock, electrical 7
Improper device output 7
Corrosion 7
Output above specifications 7
Difficult to open or close 7
Material frayed 6
Disinfection or Sterilization Issue at User Location 6
Expulsion 6
High battery impedance 5
Leak 5
Other (for use when an appropriate device code cannot be identified) 5
Implant, removal of 5
Torn material 5
Failure to conduct 5
Malfunction 4
Device or device fragments location unknown 4
Unintended collision 4
Device or device component damaged by another device 4
Unit inactivated 4
Material fragmentation 4
Arcing at electrodes 4
Cardiac enzyme evaluation, erroneous 4
Unexpected therapeutic results 4
Tears, rips, holes in device, device material 4
Energy output to patient tissue incorrect 3
Material twisted 3
Rejection 3
Unstable 3
Material integrity issue 3
Electrode(s), fracture of 3
Failure to interrogate 3
Coiled 3
Telemetry discrepancy 3
Fitting problem 3
Incorrect or inadequate result 3
Overheating of device or device component 3
Total Device Problems 24343

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 1 0 0 0 1 0 0
Class III 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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