Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
stimulator, electrical, implantable, for incontinence
Definition
PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
Product Code
EZW
Regulation Number
876.5270
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
12
24
26
19
17
23
20
27
27
19
24
43
34
46
32
23
MDR Year
MDR Reports
MDR Events
2014
4603
4603
2015
5976
5976
2016
7080
7080
2017
8095
8095
2018
5737
5737
2019
4772
4772
2020
4118
4118
2021
4479
4479
2022
4318
4318
2023
5056
5056
2024
3808
3808
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
12156
12156
Device Operates Differently Than Expected
12100
12100
Failure to Deliver Energy
9206
9206
Insufficient Information
7476
7476
Migration or Expulsion of Device
7232
7232
Inappropriate/Inadequate Shock/Stimulation
5123
5123
Unintended Collision
4393
4393
Break
3735
3735
Communication or Transmission Problem
3564
3564
Energy Output Problem
3093
3093
Battery Problem
3059
3059
Therapy Delivered to Incorrect Body Area
3011
3011
Electromagnetic Compatibility Problem
2944
2944
High impedance
2681
2681
Device Displays Incorrect Message
2415
2415
Failure to Interrogate
2306
2306
Electromagnetic Interference
2167
2167
Intermittent Continuity
1579
1579
Malposition of Device
1548
1548
Patient Device Interaction Problem
1057
1057
Connection Problem
964
964
Overheating of Device
902
902
Impedance Problem
856
856
Unstable
795
795
Device Or Device Fragments Location Unknown
725
725
Pocket Stimulation
690
690
Positioning Problem
687
687
Low Battery
657
657
Unexpected Therapeutic Results
607
607
Premature Discharge of Battery
594
594
Charging Problem
593
593
Data Problem
463
463
Material Deformation
435
435
Disconnection
405
405
Difficult to Remove
376
376
Low impedance
361
361
Environmental Compatibility Problem
243
243
No Device Output
242
242
Application Program Problem
225
225
Display or Visual Feedback Problem
220
220
Energy Output To Patient Tissue Incorrect
199
199
Human-Device Interface Problem
186
186
Appropriate Term/Code Not Available
179
179
Device Contamination with Chemical or Other Material
162
162
Loss of Data
161
161
Delayed Charge Time
156
156
Inadequate Instructions for Non-Healthcare Professional
147
147
Shipping Damage or Problem
146
146
Improper Device Output
141
141
Peeled/Delaminated
135
135
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Therapeutic Effects, Unexpected
12655
12655
Pain
11575
11575
Therapeutic Response, Decreased
8660
8660
No Known Impact Or Consequence To Patient
8596
8596
Incontinence
8207
8207
Complaint, Ill-Defined
6730
6730
No Clinical Signs, Symptoms or Conditions
6632
6632
Discomfort
5916
5916
Insufficient Information
5148
5148
Electric Shock
5077
5077
Urinary Retention
4609
4609
Urinary Frequency
4328
4328
Undesired Nerve Stimulation
3599
3599
Unspecified Infection
3220
3220
Urinary Tract Infection
2460
2460
Micturition Urgency
2047
2047
Device Overstimulation of Tissue
2025
2025
Burning Sensation
1862
1862
Device Embedded In Tissue or Plaque
1163
1163
Sleep Dysfunction
1104
1104
Ambulation Difficulties
1002
1002
Constipation
962
962
Diarrhea
922
922
Hemorrhage/Bleeding
880
880
Swelling
676
676
Malaise
597
597
Numbness
507
507
Erythema
466
466
Dysuria
448
448
Fluid Discharge
442
442
Tingling
439
439
Abdominal Pain
435
435
Muscle Spasm(s)
435
435
Itching Sensation
358
358
Wound Dehiscence
355
355
Pocket Erosion
350
350
Urinary Incontinence
331
331
Weight Changes
298
298
Nausea
298
298
Bruise/Contusion
260
260
Failure of Implant
252
252
Fever
246
246
Cramp(s)
243
243
Cramp(s) /Muscle Spasm(s)
240
240
Scar Tissue
237
237
Fall
234
234
Swelling/ Edema
230
230
Bacterial Infection
228
228
Post Operative Wound Infection
226
226
No Code Available
217
217
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
Sep-06-2024
2
Medtronic Neuromodulation
II
Aug-10-2023
3
Medtronic Neuromodulation
II
Apr-22-2022
4
Medtronic Neuromodulation
II
Nov-24-2021
5
Medtronic Neuromodulation
II
Jun-07-2019
-
-