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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 2

Device Problems
Device operates differently than expected 1793
Inappropriate shock 937
No Known Device Problem 739
High impedance 717
Failure to deliver energy 571
Migration of device or device component 415
No Information 408
Electro-magnetic interference (EMI) 361
Explanted 308
Unknown (for use when the device problem is not known) 264
Device displays error message 254
Break 219
Replace 215
Intermittent continuity 213
Connection issue 183
Electromagnetic compatibility issue 173
Unintended collision 172
Implant, reprogramming of 171
Therapy delivered to incorrect body area 169
Communication or transmission issue 157
Fracture 129
Premature discharge of battery 107
Device inoperable 105
Low battery 105
Electro-magnetic interference (EMI), compatibility/incompatibility 101
Failure to interrogate 92
Device remains implanted 83
Unexpected therapeutic results 80
Low impedance 79
Malfunction 78
Impedance issue 77
Unit inactivated 77
Device or device fragments location unknown 70
Electronic property issue 65
Malposition of device 64
Lead(s), breakage of 63
Implant, repositioning of 62
Device stops intermittently 57
Battery issue 55
Device, or device fragments remain in patient 50
Circuit breaker tripped 47
Shock, electrical 47
Unstable 38
Disconnection 37
Overheating of device or device component 33
Wire(s), breakage of 32
Material fragmentation 32
Energy output to patient tissue incorrect 31
Pocket stimulation 30
Dislodged or dislocated 27
Positioning Issue 25
Material deformation 22
Loose or intermittent connection 20
Dislodged 19
Improper device output 19
Power source issue 17
Component incompatible 16
Shelf life exceeded 16
Other (for use when an appropriate device code cannot be identified) 15
Fitting problem 15
Difficult to remove 15
Bent 14
Loss of Data 14
Unintended movement 14
Material erosion 14
Unable to obtain readings 13
Difficult to position 13
Foreign material present in device 12
Human-Device Interface Issue 12
Magnetic interference 11
Defective component 10
Out-of-box failure 10
Material separation 9
Lead(s), fracture of 9
Suspect EMI 9
Shipping damage or problem 9
Difficult to Program or Calibrate 8
Material frayed 8
Inadequate instructions for non-healthcare professional 8
Failure to disconnect 8
Kinked 8
Failure to power-up 8
Environmental control or utility issue 8
Detachment of device component 8
Peeled 8
Telemetry discrepancy 7
No device output 7
Component missing 7
Use of Device Issue 6
Intermittent shock 6
Improper or incorrect procedure or method 6
Material twisted 6
Implant, removal of 6
Device damaged prior to use 6
Inadequate training 6
Expulsion 6
Loose 6
Electrical shorting 5
Reset issue 5
Device or device component damaged by another device 5
Total Device Problems 10926

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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