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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)
2016 2017 2018 2019 2020 2021
54 54 38 49 85 2

MDR Year MDR Reports MDR Events
2016 7078 7078
2017 8095 8095
2018 5737 5737
2019 4772 4772
2020 4118 4118

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 7892 7892
Adverse Event Without Identified Device or Use Problem 6264 6264
Failure to Deliver Energy 5156 5156
Migration or Expulsion of Device 3505 3505
Insufficient Information 3304 3304
Unintended Collision 2454 2454
Inappropriate/Inadequate Shock/Stimulation 2416 2416
Break 1741 1741
Therapy Delivered to Incorrect Body Area 1696 1696
Electromagnetic Compatibility Problem 1552 1552
Energy Output Problem 1529 1529
Device Displays Incorrect Message 1521 1521
Communication or Transmission Problem 1437 1437
Battery Problem 1323 1323
High impedance 1226 1226
Electromagnetic Interference 1104 1104
Failure to Interrogate 928 928
Intermittent Continuity 844 844
Malposition of Device 743 743
Patient Device Interaction Problem 601 601
Impedance Problem 500 500
Low Battery 486 486
Overheating of Device 482 482
Connection Problem 474 474
Device Or Device Fragments Location Unknown 427 427
Unexpected Therapeutic Results 391 391
Positioning Problem 364 364
Unstable 355 355
Pocket Stimulation 349 349
Premature Discharge of Battery 315 315
Low impedance 227 227
Material Deformation 207 207
Disconnection 188 188
Data Problem 186 186
No Device Output 145 145
Environmental Compatibility Problem 129 129
Appropriate Term/Code Not Available 118 118
Energy Output To Patient Tissue Incorrect 114 114
Shipping Damage or Problem 112 112
Difficult to Remove 111 111
Inadequate Instructions for Non-Healthcare Professional 108 108
Peeled/Delaminated 104 104
Human-Device Interface Problem 99 99
Loss of Data 97 97
Device Contamination with Chemical or Other Material 97 97
Display or Visual Feedback Problem 95 95
Improper Device Output 87 87
Charging Problem 57 57
Unable to Obtain Readings 48 48
Therapeutic or Diagnostic Output Failure 47 47
Ambient Noise Problem 42 42
Vibration 40 40
Stretched 39 39
Labelling, Instructions for Use or Training Problem 37 37
Device Difficult to Program or Calibrate 37 37
Failure to Power Up 35 35
Material Twisted/Bent 31 31
Patient-Device Incompatibility 30 30
Difficult to Insert 29 29
Patient Lead 24 24
Application Program Problem 24 24
Electro-Static Discharge 22 22
Degraded 21 21
Wire 19 19
Inadequacy of Device Shape and/or Size 17 17
Mechanical Problem 17 17
Use of Device Problem 17 17
Improper or Incorrect Procedure or Method 16 16
Shelf Life Exceeded 15 15
Noise, Audible 15 15
Material Integrity Problem 14 14
Unintended Movement 13 13
Component Missing 12 12
Loss of Power 12 12
Bent 12 12
Migration 11 11
Loose or Intermittent Connection 10 10
Material Perforation 10 10
Detachment of Device or Device Component 10 10
Device Dislodged or Dislocated 10 10
Output Problem 10 10
Defective Device 9 9
Delayed Charge Time 9 9
Use of Incorrect Control Settings 8 8
Device Sensing Problem 7 7
Screen 7 7
Battery 7 7
Entrapment of Device 6 6
Defective Component 6 6
Device Fell 6 6
Unsealed Device Packaging 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Inadequate or Insufficient Training 5 5
Activation, Positioning or SeparationProblem 5 5
Wireless Communication Problem 5 5
Device Markings/Labelling Problem 5 5
Contamination 5 5
Self-Activation or Keying 4 4
Computer Software Problem 4 4
Inappropriate or Unexpected Reset 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Therapeutic Effects, Unexpected 9029 9029
No Known Impact Or Consequence To Patient 6565 6565
Pain 6491 6491
Therapeutic Response, Decreased 6083 6083
Complaint, Ill-Defined 5327 5327
Incontinence 4838 4838
Discomfort 3387 3387
Urinary Retention 2629 2629
Urinary Frequency 2608 2608
Electric Shock 2404 2404
Undesired Nerve Stimulation 1946 1946
Unspecified Infection 1803 1803
Urinary Tract Infection 1579 1579
Micturition Urgency 1255 1255
Device Overstimulation of Tissue 1116 1116
Burning Sensation 1022 1022
Sleep Dysfunction 716 716
Diarrhea 614 614
Constipation 589 589
Ambulation Difficulties 566 566
Hemorrhage/Bleeding 500 500
Swelling 499 499
Device Embedded In Tissue or Plaque 464 464
Malaise 361 361
Muscle Spasm(s) 319 319
Tingling 307 307
Numbness 300 300
Abdominal Pain 299 299
Erythema 264 264
Dysuria 254 254
No Clinical Signs, Symptoms or Conditions 246 246
Itching Sensation 222 222
Fluid Discharge 221 221
Weight Changes 196 196
Cramp(s) 192 192
Insufficient Information 190 190
Nausea 188 188
Pocket Erosion 180 180
No Code Available 168 168
Fever 168 168
Fall 166 166
Bruise/Contusion 159 159
Anxiety 158 158
Fatigue 150 150
Wound Dehiscence 146 146
Irritation 135 135
Distress 125 125
Inflammation 119 119
Hypersensitivity/Allergic reaction 117 117
Staphylococcus Aureus 113 113
Scar Tissue 112 112
Headache 112 112
Bacterial Infection 111 111
Purulent Discharge 110 110
Post Operative Wound Infection 110 110
Shaking/Tremors 104 104
Nerve Damage 103 103
Dizziness 100 100
Hematuria 99 99
Impaired Healing 93 93
Vomiting 92 92
Flatus 89 89
Twitching 82 82
Muscular Rigidity 78 78
Foreign Body Reaction 78 78
Seizures 77 77
Fungal Infection 76 76
Abdominal Distention 75 75
Weakness 73 73
Rash 70 70
Alteration In Body Temperature 65 65
Muscle Weakness 64 64
Skin Irritation 62 62
Cognitive Changes 59 59
Loss of consciousness 57 57
Dehydration 57 57
Confusion/ Disorientation 57 57
Seroma 56 56
Hematoma 54 54
Depression 49 49
High Blood Pressure/ Hypertension 47 47
Abscess 46 46
Erosion 46 46
Emotional Changes 45 45
Sepsis 43 43
Injury 43 43
Test Result 41 41
Viral Infection 39 39
Sweating 39 39
Chills 38 38
Skin Inflammation 37 37
Edema 36 36
Stroke/CVA 34 34
Reaction 33 33
Irritability 33 33
Neuropathy 33 33
Abdominal Cramps 32 32
Prolapse 32 32
Tissue Breakdown 30 30
Chest Pain 29 29

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Jun-07-2019
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