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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
6 14 12 24 48 38 10

Device Problems
Device operates differently than expected 738
Inappropriate shock 699
High impedance 563
No Information 401
No Known Device Problem 371
Explanted 308
Unknown (for use when the device problem is not known) 264
Electro-magnetic interference (EMI) 252
Migration of device or device component 232
Replace 215
Implant, reprogramming of 171
Device operational issue 169
Fracture 128
Device inoperable 105
Electro-magnetic interference (EMI), compatibility/incompatibility 101
Intermittent continuity 93
Premature discharge of battery 88
Device remains implanted 83
Connection issue 81
Malfunction 78
Unit inactivated 77
Electronic property issue 65
Lead(s), breakage of 63
Implant, repositioning of 62
Break 60
Device stops intermittently 57
Low impedance 56
Low battery 52
Device, or device fragments remain in patient 50
Circuit breaker tripped 47
Shock, electrical 47
Impedance issue 42
Communication or transmission issue 34
Device displays error message 32
Wire(s), breakage of 32
Material fragmentation 31
Therapy delivered to incorrect body area 28
Battery issue 27
Dislodged or dislocated 27
Failure to interrogate 26
Unexpected therapeutic results 22
Loose or intermittent connection 20
Dislodged 19
Disconnection 19
Power source issue 17
Component incompatible 16
Malposition of device 16
Fitting problem 15
Other (for use when an appropriate device code cannot be identified) 15
Shelf life exceeded 14
Material erosion 14
Unintended movement 14
Difficult to position 13
Magnetic interference 11
Bent 11
Defective component 10
Out-of-box failure 10
Suspect EMI 9
Material separation 9
Lead(s), fracture of 9
Detachment of device component 8
Material frayed 8
Kinked 8
Failure to disconnect 8
Telemetry discrepancy 7
Material twisted 6
Implant, removal of 6
Intermittent shock 6
Expulsion 6
Failure to power-up 6
Improper or incorrect procedure or method 6
Device damaged prior to use 6
Physical property issue 6
Difficult to remove 5
Reset issue 5
Failure to shut off 5
Electrical shorting 5
Device or device component damaged by another device 5
Positioning Issue 5
Component(s), broken 4
Device Issue 4
Component missing 4
Difficult to insert 4
High battery impedance 4
Low battery impedance 4
Improper device output 4
Loose 4
Slippage of device or device component 4
Device or device fragments location unknown 4
Inadequate training 4
Program, failure to 3
Crack 3
Device remains activated 3
Steering wire problem 3
Circuit Failure 3
Device contamination with blood or blood product 3
Use of Device Issue 3
Misconnection 3
Buckled material 3
Intermittent capture 3
Total Device Problems 6529

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 0 0 0 0 0 0
Class III 0 1 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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