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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 46

Device Problems
Device operates differently than expected 3477
Failure to deliver energy 1388
No Known Device Problem 1381
Inappropriate shock 1208
High impedance 857
Migration of device or device component 695
Device displays error message 556
Electro-magnetic interference (EMI) 502
Unintended collision 454
Therapy delivered to incorrect body area 423
No Information 408
Break 402
Intermittent continuity 372
Electromagnetic compatibility issue 361
Explanted 308
Communication or transmission issue 289
Unknown (for use when the device problem is not known) 264
Connection issue 259
Replace 215
Low battery 192
Failure to interrogate 184
Implant, reprogramming of 171
Device or device fragments location unknown 166
Malposition of device 156
Unexpected therapeutic results 150
Premature discharge of battery 134
Impedance issue 134
Fracture 129
Overheating of device or device component 109
Battery issue 106
Device inoperable 105
Low impedance 104
Electro-magnetic interference (EMI), compatibility/incompatibility 101
Device remains implanted 83
Malfunction 78
Unit inactivated 77
Pocket stimulation 77
Unstable 73
Positioning Issue 67
Electronic property issue 65
Disconnection 64
Lead(s), breakage of 63
Implant, repositioning of 62
Energy output to patient tissue incorrect 60
Device stops intermittently 57
Device, or device fragments remain in patient 50
Shock, electrical 47
Circuit breaker tripped 47
Improper device output 43
Material deformation 40
No device output 34
Material fragmentation 32
Wire(s), breakage of 32
Foreign material present in device 30
Loss of Data 28
Inadequate instructions for non-healthcare professional 28
Dislodged or dislocated 27
Environmental control or utility issue 21
Difficult to remove 21
Unable to obtain readings 20
Loose or intermittent connection 20
Dislodged 19
Shelf life exceeded 18
Shipping damage or problem 17
Human-Device Interface Issue 17
Power source issue 17
Component incompatible 16
Failure to power-up 16
Bent 15
Fitting problem 15
Other (for use when an appropriate device code cannot be identified) 15
Material erosion 14
Unintended movement 14
Difficult to position 13
Peeled 12
Difficult to Program or Calibrate 11
Magnetic interference 11
Defective component 10
Out-of-box failure 10
Use of Device Issue 9
Vibration 9
Electro-static discharge 9
Material separation 9
Lead(s), fracture of 9
Incorrect display 9
Ambient noise issue 9
Suspect EMI 9
Failure to disconnect 8
Detachment of device component 8
Kinked 8
Material frayed 8
Telemetry discrepancy 7
Inadequate training 7
Component missing 7
Device damaged prior to use 6
Implant, removal of 6
Improper or incorrect procedure or method 6
Intermittent shock 6
Difficult to insert 6
Instruction for use issue 6
Total Device Problems 17527

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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