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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 36

Device Problems
Device operates differently than expected 2905
Failure to deliver energy 1125
No Known Device Problem 1120
Inappropriate shock 1117
High impedance 816
Migration of device or device component 589
Device displays error message 464
Electro-magnetic interference (EMI) 463
No Information 408
Break 353
Unintended collision 346
Therapy delivered to incorrect body area 326
Intermittent continuity 315
Explanted 308
Electromagnetic compatibility issue 303
Unknown (for use when the device problem is not known) 264
Communication or transmission issue 247
Connection issue 234
Replace 215
Implant, reprogramming of 171
Failure to interrogate 160
Low battery 155
Device or device fragments location unknown 142
Unexpected therapeutic results 130
Fracture 129
Malposition of device 125
Premature discharge of battery 124
Impedance issue 113
Device inoperable 105
Electro-magnetic interference (EMI), compatibility/incompatibility 101
Low impedance 94
Battery issue 92
Overheating of device or device component 89
Device remains implanted 83
Malfunction 78
Unit inactivated 77
Unstable 65
Electronic property issue 65
Pocket stimulation 64
Lead(s), breakage of 63
Implant, repositioning of 62
Device stops intermittently 57
Energy output to patient tissue incorrect 51
Positioning Issue 51
Disconnection 50
Device, or device fragments remain in patient 50
Shock, electrical 47
Circuit breaker tripped 47
Improper device output 35
Material deformation 34
Material fragmentation 32
Wire(s), breakage of 32
No device output 27
Dislodged or dislocated 27
Loss of Data 25
Foreign material present in device 21
Inadequate instructions for non-healthcare professional 20
Loose or intermittent connection 20
Dislodged 19
Difficult to remove 19
Unable to obtain readings 19
Shelf life exceeded 18
Human-Device Interface Issue 17
Power source issue 17
Component incompatible 16
Bent 15
Shipping damage or problem 15
Fitting problem 15
Other (for use when an appropriate device code cannot be identified) 15
Environmental control or utility issue 15
Unintended movement 14
Material erosion 14
Difficult to position 13
Failure to power-up 12
Magnetic interference 11
Peeled 11
Difficult to Program or Calibrate 10
Defective component 10
Out-of-box failure 10
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
Use of Device Issue 7
Vibration 7
Telemetry discrepancy 7
Inadequate training 7
Incorrect display 7
Difficult to insert 6
Loose 6
Improper or incorrect procedure or method 6
Electro-static discharge 6
Device damaged prior to use 6
Intermittent shock 6
Implant, removal of 6
Expulsion 6
Total Device Problems 15285

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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