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TPLC
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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
12
MDR Year
MDR Reports
MDR Events
2014
4602
4602
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
2254
2254
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
12100
12100
Adverse Event Without Identified Device or Use Problem
11779
11779
Failure to Deliver Energy
9075
9075
Insufficient Information
7100
7100
Migration or Expulsion of Device
7016
7016
Inappropriate/Inadequate Shock/Stimulation
4985
4985
Unintended Collision
4292
4292
Break
3630
3630
Communication or Transmission Problem
3417
3417
Battery Problem
2978
2978
Therapy Delivered to Incorrect Body Area
2961
2961
Energy Output Problem
2935
2935
Electromagnetic Compatibility Problem
2867
2867
High impedance
2605
2605
Device Displays Incorrect Message
2415
2415
Failure to Interrogate
2185
2185
Electromagnetic Interference
2120
2120
Intermittent Continuity
1561
1561
Malposition of Device
1487
1487
Patient Device Interaction Problem
1008
1008
Connection Problem
946
946
Overheating of Device
880
880
Impedance Problem
835
835
Unstable
774
774
Device Or Device Fragments Location Unknown
725
725
Positioning Problem
675
675
Pocket Stimulation
671
671
Low Battery
657
657
Unexpected Therapeutic Results
607
607
Premature Discharge of Battery
564
564
Charging Problem
553
553
Data Problem
431
431
Material Deformation
421
421
Disconnection
391
391
Low impedance
359
359
Difficult to Remove
354
354
Environmental Compatibility Problem
242
242
No Device Output
238
238
Application Program Problem
225
225
Display or Visual Feedback Problem
209
209
Energy Output To Patient Tissue Incorrect
199
199
Human-Device Interface Problem
183
183
Appropriate Term/Code Not Available
179
179
Device Contamination with Chemical or Other Material
160
160
Loss of Data
155
155
Inadequate Instructions for Non-Healthcare Professional
147
147
Delayed Charge Time
147
147
Shipping Damage or Problem
143
143
Improper Device Output
141
141
Peeled/Delaminated
135
135
Vibration
112
112
Unable to Obtain Readings
109
109
Therapeutic or Diagnostic Output Failure
105
105
Migration
77
77
Difficult to Insert
74
74
Ambient Noise Problem
68
68
Material Twisted/Bent
60
60
Stretched
58
58
Use of Device Problem
58
58
Device Difficult to Program or Calibrate
55
55
Labelling, Instructions for Use or Training Problem
54
54
Failure to Power Up
53
53
Noise, Audible
49
49
Improper or Incorrect Procedure or Method
46
46
Shelf Life Exceeded
39
39
Degraded
38
38
Electro-Static Discharge
37
37
Compatibility Problem
37
37
Patient-Device Incompatibility
35
35
Component Missing
33
33
Failure to Charge
32
32
Inadequacy of Device Shape and/or Size
31
31
Material Perforation
23
23
Bent
21
21
Mechanical Problem
17
17
Lack of Effect
17
17
Loss of Power
15
15
Entrapment of Device
15
15
Device Inoperable
14
14
Material Integrity Problem
14
14
Unintended Movement
13
13
Device Dislodged or Dislocated
13
13
Fracture
13
13
Device Markings/Labelling Problem
12
12
Defective Device
12
12
Unauthorized Access to Computer System
12
12
Wireless Communication Problem
11
11
Output Problem
11
11
Detachment of Device or Device Component
11
11
Use of Incorrect Control/Treatment Settings
11
11
Loose or Intermittent Connection
11
11
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Unsealed Device Packaging
9
9
Contamination
9
9
Material Protrusion/Extrusion
9
9
Device Sensing Problem
8
8
Inadequate or Insufficient Training
8
8
Defective Component
7
7
Activation, Positioning or Separation Problem
7
7
Self-Activation or Keying
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Therapeutic Effects, Unexpected
12655
12655
Pain
11283
11283
Therapeutic Response, Decreased
8660
8660
No Known Impact Or Consequence To Patient
8596
8596
Incontinence
7951
7951
Complaint, Ill-Defined
6730
6730
No Clinical Signs, Symptoms or Conditions
6060
6060
Discomfort
5776
5776
Electric Shock
4940
4940
Insufficient Information
4739
4739
Urinary Retention
4511
4511
Urinary Frequency
4251
4251
Undesired Nerve Stimulation
3532
3532
Unspecified Infection
3124
3124
Urinary Tract Infection
2440
2440
Micturition Urgency
2009
2009
Device Overstimulation of Tissue
1975
1975
Burning Sensation
1822
1822
Device Embedded In Tissue or Plaque
1127
1127
Sleep Dysfunction
1077
1077
Ambulation Difficulties
981
981
Constipation
945
945
Diarrhea
903
903
Hemorrhage/Bleeding
851
851
Swelling
676
676
Malaise
583
583
Numbness
495
495
Erythema
456
456
Tingling
439
439
Muscle Spasm(s)
435
435
Dysuria
435
435
Fluid Discharge
431
431
Abdominal Pain
430
430
Itching Sensation
345
345
Pocket Erosion
342
342
Wound Dehiscence
341
341
Urinary Incontinence
308
308
Nausea
295
295
Weight Changes
293
293
Bruise/Contusion
254
254
Fever
244
244
Cramp(s)
243
243
Failure of Implant
242
242
Fall
230
230
Scar Tissue
230
230
Bacterial Infection
222
222
Post Operative Wound Infection
219
219
Cramp(s) /Muscle Spasm(s)
219
219
No Code Available
217
217
Swelling/ Edema
212
212
Anxiety
211
211
Nerve Damage
210
210
Distress
205
205
Inflammation
204
204
Fatigue
204
204
Irritation
201
201
Hypersensitivity/Allergic reaction
199
199
Impaired Healing
198
198
Purulent Discharge
181
181
Staphylococcus Aureus
177
177
Headache
172
172
Paresthesia
167
167
Shaking/Tremors
165
165
Dizziness
163
163
Twitching
157
157
Hematuria
151
151
Foreign Body Reaction
147
147
Flatus
143
143
Vomiting
138
138
Muscular Rigidity
133
133
Rash
123
123
Muscle Weakness
119
119
Abdominal Distention
118
118
Hematoma
117
117
Seizures
111
111
Erosion
105
105
Loss of consciousness
104
104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
103
103
Fungal Infection
102
102
Seroma
96
96
Weakness
95
95
Cognitive Changes
94
94
Confusion/ Disorientation
82
82
Alteration In Body Temperature
82
82
Dehydration
82
82
Abscess
80
80
Fecal Incontinence
80
80
Skin Irritation
78
78
High Blood Pressure/ Hypertension
75
75
Sepsis
72
72
Skin Erosion
68
68
Test Result
67
67
Injury
66
66
Depression
65
65
Irritability
65
65
Chills
65
65
Prolapse
65
65
Skin Inflammation/ Irritation
65
65
Emotional Changes
61
61
Stroke/CVA
58
58
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
Aug-10-2023
2
Medtronic Neuromodulation
II
Apr-22-2022
3
Medtronic Neuromodulation
II
Nov-24-2021
4
Medtronic Neuromodulation
II
Jun-07-2019
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