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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
No Known Device Problem 324
Device operates differently than expected 221
Impedance issue 59
High impedance 46
Migration of device or device component 38
Therapy delivered to incorrect body area 14
No Information 12
Fracture 10
Inappropriate shock 9
Device remains implanted 8
Intermittent continuity 8
Break 6
Replace 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
Disconnection 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
Low battery 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
Dislodged 1
Elective removal 1
Shock, electrical 1
Failure to deliver energy 1
Failure to charge 1
Battery failure 1
Premature discharge of battery 1
Bent 1
Kinked 1
Power Conditioning Issue 1
Premature explantation 1
Total Device Problems 829

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