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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 6333
No Known Device Problem 4555
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 219
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 36
Detachment of device component 33
Low battery 32
Self-activation or keying 32
Difficult to insert 28
Sticking 26
Output issue 26
Premature end-of-life indicator 25
Replace 24
Fluid leak 21
Battery issue 19
Electro-magnetic interference (EMI) 18
Premature discharge of battery 18
Detachment 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
Dislodged or dislocated 14
Cut in material 13
Implant, reprogramming of 13
Bent 13
Device remains activated 12
Difficult to remove 11
Improper or incorrect procedure or method 11
Wire(s), breakage of 11
Connection issue 10
Intermittent continuity 10
Low battery impedance 10
Device handling issue 10
Difficult to position 8
Device, or device fragments remain in patient 8
Material separation 8
Out-of-box failure 7
Output above specifications 7
Corrosion 7
Shock, electrical 7
Failure to deliver energy 7
Improper device output 7
Difficult to open or close 7
Expulsion 6
Material frayed 6
Disinfection or Sterilization Issue at User Location 6
Implant, removal of 5
Other (for use when an appropriate device code cannot be identified) 5
Failure to conduct 5
Leak 5
High battery impedance 5
Torn material 5
Device or device component damaged by another device 4
Unintended collision 4
Overheating of device or device component 4
Material fragmentation 4
Unit inactivated 4
Arcing at electrodes 4
Tears, rips, holes in device, device material 4
Unexpected therapeutic results 4
Cardiac enzyme evaluation, erroneous 4
Malfunction 4
Device or device fragments location unknown 4
Battery impedance issue 3
Telemetry discrepancy 3
Fitting problem 3
Unstable 3
Rejection 3
Incorrect or inadequate result 3
Material erosion 3
Electrode(s), fracture of 3
Energy output to patient tissue incorrect 3
Computer software issue 3
Coiled 3
Total Device Problems 24349

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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