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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 2017
6 14 12 24 48 38 34 46 40 54 16

Device Problems
Device operates differently than expected 5018
No Known Device Problem 2199
Failure to deliver energy 2127
Inappropriate shock 1479
Migration of device or device component 1110
High impedance 997
Device displays error message 800
Unintended collision 785
Therapy delivered to incorrect body area 655
Electro-magnetic interference (EMI) 627
Break 591
Electromagnetic compatibility issue 515
Intermittent continuity 485
Communication or transmission issue 450
No Information 408
Connection issue 309
Explanted 308
Low battery 293
Failure to interrogate 276
Unknown (for use when the device problem is not known) 264
Device or device fragments location unknown 254
Malposition of device 240
Replace 215
Unexpected therapeutic results 215
Impedance issue 208
Overheating of device or device component 179
Premature discharge of battery 175
Implant, reprogramming of 171
Battery issue 157
Fracture 129
Low impedance 118
Pocket stimulation 118
Positioning Issue 116
Unstable 112
Device inoperable 105
Electro-magnetic interference (EMI), compatibility/incompatibility 101
Energy output to patient tissue incorrect 88
Disconnection 88
Device remains implanted 83
Malfunction 78
Unit inactivated 77
Material deformation 70
Electronic property issue 65
Lead(s), breakage of 63
Implant, repositioning of 62
Device stops intermittently 57
Improper device output 54
Device, or device fragments remain in patient 50
Shock, electrical 47
Circuit breaker tripped 47
Environmental control or utility issue 47
No device output 44
Foreign material present in device 39
Inadequate instructions for non-healthcare professional 38
Loss of Data 35
Difficult to remove 34
Wire(s), breakage of 32
Material fragmentation 32
Human-Device Interface Issue 32
Shipping damage or problem 29
Dislodged or dislocated 27
Shelf life exceeded 24
Unable to obtain readings 23
Peeled 21
Failure to power-up 20
Loose or intermittent connection 20
Incorrect display 20
Dislodged 19
Difficult to Program or Calibrate 18
Bent 17
Power source issue 17
Component incompatible 16
Instruction for use issue 15
Fitting problem 15
Other (for use when an appropriate device code cannot be identified) 15
Ambient noise issue 15
Unintended movement 14
Material erosion 14
Electro-static discharge 13
Difficult to position 13
Component missing 11
Magnetic interference 11
Out-of-box failure 10
Defective component 10
Use of Device Issue 10
Vibration 10
Material separation 9
Lead(s), fracture of 9
Suspect EMI 9
Failure to disconnect 8
Kinked 8
Material frayed 8
Detachment of device component 8
Inadequate training 8
Telemetry discrepancy 7
Contamination during use 7
Difficult to insert 7
Loose 6
Stretched 6
Size incorrect for patient 6
Total Device Problems 24124

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 2 0 0 0 0 0 0 0 0 0 0
Class III 0 1 0 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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