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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, electrical, implanted, for parkinsonian tremor
Product CodeMHY
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
18 37 45 36 42 4

Device Problems
Adverse Event Without Identified Device or Use Problem 3472
Device Operates Differently Than Expected 2220
High impedance 2010
Failure to Deliver Energy 1112
Battery Problem 1052
Charging Problem 899
Low impedance 853
Component Misassembled 826
Break 820
Device Displays Incorrect Message 802
Communication or Transmission Problem 734
Inappropriate Shock 684
Unintended Collision 593
Insufficient Information 538
Low Battery 533
Premature Discharge of Battery 479
Electromagnetic Compatibility Problem 456
Migration or Expulsion of Device 411
Malposition of device 389
Energy Output Problem 388
Delayed Charge Time 305
Impedance Problem 293
Therapy Delivered to Incorrect Body Area 279
Failure to Interrogate 262
Intermittent Continuity 256
Electromagnetic Interference 226
Connection Problem 211
Shipping Damage or Problem 193
Improper or Incorrect Procedure or Method 175
Material Deformation 172
Unstable 168
Premature Elective Replacement Indicator 135
Therapeutic or Diagnostic Output Failure 131
Display or Visual Feedback Problem 124
No Device Output 109
Material Integrity Problem 108
Overheating of Device 93
Pocket Stimulation 92
Device Or Device Fragments Location Unknown 76
Patient Device Interaction Problem 69
Positioning Problem 64
Bent 61
Device Contamination with Chemical or Other Material 56
Data Problem 52
Material Twisted / Bent 52
Incorrect, Inadequate or Imprecise Result or Readings 47
Disconnection 43
Loss of Data 42
Activation, Positioning or Separation Problem 39
Unexpected Therapeutic Results 38
Use of Device Problem 37
Human-Device Interface Problem 34
Environmental Compatibility Problem 31
Energy Output To Patient Tissue Incorrect 30
Fracture 29
Improper Device Output 27
Failure to Power Up 25
Device Difficult to Program or Calibrate 25
Shelf Life Exceeded 24
Component Missing 18
Appropriate Term/Code Not Available 18
Difficult to Insert 17
Inadequacy of Device Shape and/or Size 17
Vibration 16
Peeled / Delaminated 16
Unable to Obtain Readings 16
Wireless Communication Problem 16
Device Damaged by Another Device 15
Migration 14
Difficult to Open or Close 13
Difficult to Remove 12
Ambient Noise Problem 10
Electro-Static Discharge 9
Device Inoperable 9
Manufacturing, Packaging or Shipping Problem 9
Device Markings / Labelling Problem 9
Labelling, Instructions for Use or Training Problem 8
Application Program Freezes, Becomes Nonfunctional 8
Defective Device 6
Unintended Movement 6
Stretched 6
Noise, Audible 6
Material Frayed 5
Degraded 5
Failure to Advance 5
Device Contaminated during manufacture or shipping 5
Premature End-of-Life Indicator 4
Inadequate Instructions for Non-Healthcare Professional 4
Unauthorized Access to Computer System 3
Mechanical Problem 3
Use of Incorrect Control Settings 3
Inadequate or Insufficient Training 3
Contamination During Use 3
Temperature Problem 2
Incorrect Device Or Component Shipped 2
Unsealed Device Packaging 2
Coil 2
Wire 1
Device Dislodged or Dislocated 1
Accessory Incompatible 1
Total Device Problems 23832

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Aug-23-2017
2 Medtronic Neuromodulation II Dec-03-2016
3 Medtronic Neuromodulation II Aug-24-2016
4 Medtronic Neuromodulation II Aug-19-2016
5 Medtronic Neuromodulation II May-15-2015
6 St. Jude Medical, Inc. II Dec-10-2018
7 St. Jude Medical, Inc. II Oct-17-2017
8 St. Jude Medical, Inc. II Jul-07-2017

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