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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, peripheral nerve, implanted (pain relief)
Regulation Description Implanted peripheral nerve stimulator for pain relief.
Product CodeGZF
Regulation Number 882.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED NEUROMODULATION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BIONESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Device operates differently than expected 218
No Known Device Problem 136
Impedance issue 47
High impedance 39
Migration of device or device component 35
Therapy delivered to incorrect body area 14
Inappropriate shock 9
No Information 9
Device remains implanted 8
Intermittent continuity 8
Fracture 7
Replace 5
Break 5
Self-activation or keying 4
Device stops intermittently 4
Low impedance 4
Temperature issue 4
Malposition of device 4
Malfunction 3
Unintended movement 3
Implant, reprogramming of 3
No device output 3
Explanted 3
Failure, intermittent 2
Corrosion 2
Unknown (for use when the device problem is not known) 2
Improper or incorrect procedure or method 2
Communication or transmission issue 2
Dislodged or dislocated 2
Difficult to advance 1
Battery issue 1
Fitting problem 1
Wire(s), breakage of 1
Intermittent shock 1
Device inoperable 1
Use of Device Issue 1
Device, or device fragments remain in patient 1
Disconnection 1
Dislodged 1
Elective removal 1
Shock, electrical 1
Failure to charge 1
Battery failure 1
Bent 1
Kinked 1
Power Conditioning Issue 1
Premature explantation 1
Total Device Problems 605

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