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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
6 14 12 24 48 38 34 46 40 10

Device Problems
Device operates differently than expected 2066
Inappropriate shock 980
No Known Device Problem 819
High impedance 743
Failure to deliver energy 729
Migration of device or device component 456
No Information 408
Electro-magnetic interference (EMI) 385
Device displays error message 314
Explanted 308
Unknown (for use when the device problem is not known) 264
Break 255
Intermittent continuity 241
Unintended collision 223
Replace 215
Electromagnetic compatibility issue 208
Therapy delivered to incorrect body area 206
Connection issue 197
Communication or transmission issue 184
Implant, reprogramming of 171
Fracture 129
Low battery 118
Failure to interrogate 115
Premature discharge of battery 110
Device inoperable 105
Electro-magnetic interference (EMI), compatibility/incompatibility 101
Unexpected therapeutic results 96
Impedance issue 92
Device or device fragments location unknown 85
Low impedance 85
Device remains implanted 83
Malfunction 78
Malposition of device 78
Unit inactivated 77
Battery issue 68
Electronic property issue 65
Lead(s), breakage of 63
Implant, repositioning of 62
Device stops intermittently 57
Device, or device fragments remain in patient 50
Unstable 47
Overheating of device or device component 47
Circuit breaker tripped 47
Shock, electrical 47
Energy output to patient tissue incorrect 41
Disconnection 39
Pocket stimulation 36
Wire(s), breakage of 32
Material fragmentation 32
Positioning Issue 32
Material deformation 27
Dislodged or dislocated 27
Improper device output 22
Loose or intermittent connection 20
Dislodged 19
Foreign material present in device 19
Loss of Data 18
Power source issue 17
Component incompatible 16
Shelf life exceeded 16
Unable to obtain readings 15
Difficult to remove 15
Fitting problem 15
Other (for use when an appropriate device code cannot be identified) 15
Bent 14
Material erosion 14
No device output 14
Unintended movement 14
Human-Device Interface Issue 13
Difficult to position 13
Shipping damage or problem 11
Magnetic interference 11
Failure to power-up 10
Defective component 10
Out-of-box failure 10
Environmental control or utility issue 10
Suspect EMI 9
Inadequate instructions for non-healthcare professional 9
Material separation 9
Peeled 9
Lead(s), fracture of 9
Kinked 8
Material frayed 8
Detachment of device component 8
Difficult to Program or Calibrate 8
Failure to disconnect 8
Component missing 7
Telemetry discrepancy 7
Inadequate training 6
Device damaged prior to use 6
Intermittent shock 6
Improper or incorrect procedure or method 6
Use of Device Issue 6
Implant, removal of 6
Loose 6
Material twisted 6
Expulsion 6
Failure to shut off 5
Electrical shorting 5
Device or device component damaged by another device 5
Total Device Problems 12062

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