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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 26

Device Problems
Device operates differently than expected 2617
Inappropriate shock 1071
No Known Device Problem 1006
Failure to deliver energy 991
High impedance 794
Migration of device or device component 545
Electro-magnetic interference (EMI) 441
Device displays error message 414
No Information 408
Break 323
Unintended collision 314
Explanted 308
Intermittent continuity 293
Therapy delivered to incorrect body area 287
Electromagnetic compatibility issue 273
Unknown (for use when the device problem is not known) 264
Communication or transmission issue 230
Connection issue 227
Replace 215
Implant, reprogramming of 171
Failure to interrogate 148
Low battery 144
Fracture 129
Premature discharge of battery 122
Device or device fragments location unknown 120
Unexpected therapeutic results 111
Malposition of device 108
Impedance issue 105
Device inoperable 105
Electro-magnetic interference (EMI), compatibility/incompatibility 101
Low impedance 91
Battery issue 86
Device remains implanted 83
Malfunction 78
Unit inactivated 77
Overheating of device or device component 76
Electronic property issue 65
Lead(s), breakage of 63
Implant, repositioning of 62
Unstable 61
Device stops intermittently 57
Pocket stimulation 53
Device, or device fragments remain in patient 50
Energy output to patient tissue incorrect 48
Positioning Issue 48
Circuit breaker tripped 47
Shock, electrical 47
Disconnection 47
Material deformation 33
Improper device output 33
Material fragmentation 32
Wire(s), breakage of 32
Dislodged or dislocated 27
Loss of Data 22
Foreign material present in device 20
No device output 20
Loose or intermittent connection 20
Dislodged 19
Difficult to remove 19
Shelf life exceeded 18
Unable to obtain readings 17
Power source issue 17
Human-Device Interface Issue 16
Component incompatible 16
Bent 15
Fitting problem 15
Other (for use when an appropriate device code cannot be identified) 15
Material erosion 14
Unintended movement 14
Inadequate instructions for non-healthcare professional 14
Environmental control or utility issue 14
Difficult to position 13
Shipping damage or problem 13
Failure to power-up 12
Magnetic interference 11
Peeled 11
Defective component 10
Out-of-box failure 10
Difficult to Program or Calibrate 9
Material separation 9
Lead(s), fracture of 9
Suspect EMI 9
Kinked 8
Material frayed 8
Detachment of device component 8
Failure to disconnect 8
Component missing 7
Telemetry discrepancy 7
Inadequate training 7
Incorrect display 7
Difficult to insert 6
Loose 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
Expulsion 6
Material twisted 6
Reset issue 5
Total Device Problems 14221

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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