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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, electrical, implantable, for incontinence
Regulation Description Implanted electrical urinary continence device.
Definition PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
Product CodeEZW
Regulation Number 876.5270
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
6 14 12 24 48 38 34 46 40 54 8

Device Problems
Device operates differently than expected 4501
No Known Device Problem 1882
Failure to deliver energy 1865
Inappropriate shock 1384
High impedance 957
Migration of device or device component 938
Device displays error message 733
Unintended collision 677
Electro-magnetic interference (EMI) 597
Therapy delivered to incorrect body area 586
Break 534
Electromagnetic compatibility issue 471
Intermittent continuity 450
No Information 408
Communication or transmission issue 402
Explanted 308
Connection issue 299
Unknown (for use when the device problem is not known) 264
Low battery 259
Failure to interrogate 243
Device or device fragments location unknown 228
Replace 215
Malposition of device 213
Unexpected therapeutic results 193
Impedance issue 180
Implant, reprogramming of 171
Premature discharge of battery 164
Overheating of device or device component 154
Battery issue 140
Fracture 129
Low impedance 115
Device inoperable 105
Unstable 103
Electro-magnetic interference (EMI), compatibility/incompatibility 101
Positioning Issue 99
Pocket stimulation 96
Device remains implanted 83
Energy output to patient tissue incorrect 81
Disconnection 81
Malfunction 78
Unit inactivated 77
Electronic property issue 65
Lead(s), breakage of 63
Implant, repositioning of 62
Material deformation 59
Device stops intermittently 57
Device, or device fragments remain in patient 50
Improper device output 49
Shock, electrical 47
Circuit breaker tripped 47
No device output 43
Inadequate instructions for non-healthcare professional 35
Foreign material present in device 34
Environmental control or utility issue 34
Loss of Data 33
Material fragmentation 32
Wire(s), breakage of 32
Difficult to remove 31
Human-Device Interface Issue 28
Dislodged or dislocated 27
Shelf life exceeded 23
Shipping damage or problem 22
Unable to obtain readings 22
Loose or intermittent connection 20
Failure to power-up 19
Dislodged 19
Peeled 18
Difficult to Program or Calibrate 18
Bent 17
Power source issue 17
Component incompatible 16
Fitting problem 15
Other (for use when an appropriate device code cannot be identified) 15
Incorrect display 14
Material erosion 14
Instruction for use issue 14
Unintended movement 14
Ambient noise issue 13
Difficult to position 13
Electro-static discharge 12
Magnetic interference 11
Vibration 10
Defective component 10
Component missing 10
Out-of-box failure 10
Use of Device Issue 9
Material separation 9
Lead(s), fracture of 9
Suspect EMI 9
Failure to disconnect 8
Kinked 8
Material frayed 8
Detachment of device component 8
Contamination during use 7
Difficult to insert 7
Inadequate training 7
Telemetry discrepancy 7
Improper or incorrect procedure or method 6
Device damaged prior to use 6
Intermittent shock 6
Total Device Problems 21892

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 2 0 0 0 0 0 0 0 0 0 0
Class III 0 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation III Sep-20-2008
2 Medtronic Neuromodulation II Oct-12-2007
3 Medtronic Neuromodulation II Oct-11-2007

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