Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 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 CodeEZW
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 9

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 1772 1772

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 11662 11662
Failure to Deliver Energy 9018 9018
Insufficient Information 6980 6980
Migration or Expulsion of Device 6933 6933
Inappropriate/Inadequate Shock/Stimulation 4944 4944
Unintended Collision 4257 4257
Break 3592 3592
Communication or Transmission Problem 3381 3381
Battery Problem 2946 2946
Therapy Delivered to Incorrect Body Area 2946 2946
Energy Output Problem 2891 2891
Electromagnetic Compatibility Problem 2841 2841
High impedance 2579 2579
Device Displays Incorrect Message 2415 2415
Failure to Interrogate 2160 2160
Electromagnetic Interference 2100 2100
Intermittent Continuity 1553 1553
Malposition of Device 1475 1475
Patient Device Interaction Problem 998 998
Connection Problem 941 941
Overheating of Device 872 872
Impedance Problem 827 827
Unstable 766 766
Device Or Device Fragments Location Unknown 725 725
Positioning Problem 669 669
Pocket Stimulation 666 666
Low Battery 657 657
Unexpected Therapeutic Results 607 607
Premature Discharge of Battery 551 551
Charging Problem 547 547
Data Problem 423 423
Material Deformation 419 419
Disconnection 386 386
Low impedance 357 357
Difficult to Remove 345 345
Environmental Compatibility Problem 241 241
No Device Output 236 236
Application Program Problem 225 225
Display or Visual Feedback Problem 206 206
Energy Output To Patient Tissue Incorrect 199 199
Human-Device Interface Problem 182 182
Appropriate Term/Code Not Available 178 178
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 142 142
Improper Device Output 141 141
Peeled/Delaminated 135 135
Vibration 110 110
Unable to Obtain Readings 108 108
Therapeutic or Diagnostic Output Failure 95 95
Migration 76 76
Difficult to Insert 73 73
Ambient Noise Problem 68 68
Material Twisted/Bent 59 59
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
Compatibility Problem 37 37
Patient-Device Incompatibility 35 35
Electro-Static Discharge 34 34
Component Missing 33 33
Failure to Charge 31 31
Inadequacy of Device Shape and/or Size 31 31
Material Perforation 23 23
Bent 21 21
Mechanical Problem 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
Lack of Effect 13 13
Device Dislodged or Dislocated 13 13
Device Markings/Labelling Problem 12 12
Defective Device 12 12
Fracture 12 12
Unauthorized Access to Computer System 12 12
Wireless Communication Problem 11 11
Output Problem 11 11
Use of Incorrect Control/Treatment Settings 11 11
Loose or Intermittent Connection 11 11
Detachment of Device or Device Component 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 11202 11202
Therapeutic Response, Decreased 8660 8660
No Known Impact Or Consequence To Patient 8596 8596
Incontinence 7872 7872
Complaint, Ill-Defined 6730 6730
No Clinical Signs, Symptoms or Conditions 5877 5877
Discomfort 5734 5734
Electric Shock 4898 4898
Insufficient Information 4611 4611
Urinary Retention 4486 4486
Urinary Frequency 4224 4224
Undesired Nerve Stimulation 3514 3514
Unspecified Infection 3096 3096
Urinary Tract Infection 2439 2439
Micturition Urgency 1994 1994
Device Overstimulation of Tissue 1966 1966
Burning Sensation 1812 1812
Device Embedded In Tissue or Plaque 1110 1110
Sleep Dysfunction 1071 1071
Ambulation Difficulties 975 975
Constipation 932 932
Diarrhea 898 898
Hemorrhage/Bleeding 838 838
Swelling 676 676
Malaise 580 580
Numbness 492 492
Erythema 456 456
Tingling 439 439
Muscle Spasm(s) 435 435
Dysuria 430 430
Fluid Discharge 428 428
Abdominal Pain 428 428
Itching Sensation 343 343
Pocket Erosion 339 339
Wound Dehiscence 337 337
Urinary Incontinence 305 305
Weight Changes 291 291
Nausea 290 290
Bruise/Contusion 253 253
Fever 243 243
Cramp(s) 243 243
Failure of Implant 236 236
Fall 230 230
Scar Tissue 228 228
Post Operative Wound Infection 219 219
Bacterial Infection 219 219
No Code Available 217 217
Cramp(s) /Muscle Spasm(s) 211 211
Anxiety 210 210
Nerve Damage 209 209
Swelling/ Edema 205 205
Fatigue 204 204
Distress 204 204
Inflammation 202 202
Irritation 201 201
Hypersensitivity/Allergic reaction 198 198
Impaired Healing 195 195
Purulent Discharge 180 180
Staphylococcus Aureus 177 177
Headache 169 169
Shaking/Tremors 165 165
Paresthesia 162 162
Dizziness 160 160
Twitching 157 157
Hematuria 151 151
Foreign Body Reaction 145 145
Flatus 142 142
Vomiting 137 137
Muscular Rigidity 133 133
Rash 123 123
Muscle Weakness 119 119
Abdominal Distention 117 117
Hematoma 114 114
Seizures 111 111
Erosion 105 105
Loss of consciousness 103 103
Fungal Infection 102 102
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 102 102
Weakness 95 95
Seroma 94 94
Cognitive Changes 94 94
Confusion/ Disorientation 82 82
Alteration In Body Temperature 82 82
Dehydration 82 82
Abscess 80 80
Fecal Incontinence 79 79
Skin Irritation 78 78
High Blood Pressure/ Hypertension 75 75
Sepsis 71 71
Skin Erosion 68 68
Test Result 67 67
Injury 66 66
Depression 65 65
Prolapse 65 65
Skin Inflammation/ Irritation 65 65
Irritability 64 64
Chills 64 64
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
-
-