| Device Type ID | 3842 |
| Device Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MHY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3842 |
| Device | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Product Code | MHY |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2817 |
Device Operates Differently Than Expected | 2238 |
High Impedance | 1636 |
Failure To Deliver Energy | 943 |
Component Misassembled | 824 |
Battery Problem | 824 |
Device Displays Incorrect Message | 806 |
Charging Problem | 720 |
Break | 696 |
Low Impedance | 695 |
Communication Or Transmission Problem | 602 |
Inappropriate Shock | 570 |
Low Battery | 539 |
Unintended Collision | 504 |
Premature Discharge Of Battery | 399 |
Electromagnetic Compatibility Problem | 382 |
Migration Or Expulsion Of Device | 354 |
Insufficient Information | 302 |
Malposition Of Device | 295 |
Delayed Charge Time | 257 |
Therapy Delivered To Incorrect Body Area | 246 |
Energy Output Problem | 236 |
Intermittent Continuity | 234 |
Impedance Problem | 226 |
Failure To Interrogate | 216 |
Electromagnetic Interference | 173 |
Connection Problem | 171 |
Shipping Damage Or Problem | 145 |
Material Deformation | 144 |
Unstable | 141 |
Improper Or Incorrect Procedure Or Method | 123 |
Premature Elective Replacement Indicator | 117 |
Display Or Visual Feedback Problem | 103 |
No Device Output | 96 |
Pocket Stimulation | 87 |
Material Integrity Problem | 86 |
Overheating Of Device | 80 |
Device Or Device Fragments Location Unknown | 76 |
Bent | 61 |
Positioning Problem | 50 |
Device Contamination With Chemical Or Other Material | 50 |
Therapeutic Or Diagnostic Output Failure | 45 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 41 |
Activation, Positioning Or Separation Problem | 37 |
Human-Device Interface Problem | 34 |
Patient Device Interaction Problem | 34 |
Use Of Device Problem | 33 |
Disconnection | 32 |
Material Twisted / Bent | 30 |
Energy Output To Patient Tissue Incorrect | 30 |
Unexpected Therapeutic Results | 30 |
Data Problem | 29 |
Loss Of Data | 28 |
Improper Device Output | 27 |
Environmental Compatibility Problem | 27 |
Shelf Life Exceeded | 24 |
Fracture | 24 |
Appropriate Term/Code Not Available | 19 |
Device Difficult To Program Or Calibrate | 19 |
Failure To Power Up | 19 |
Component Missing | 16 |
Peeled / Delaminated | 13 |
Device Damaged By Another Device | 12 |
Unable To Obtain Readings | 12 |
Difficult To Open Or Close | 12 |
Vibration | 12 |
Inadequacy Of Device Shape And/or Size | 11 |
Difficult To Insert | 9 |
Ambient Noise Problem | 9 |
Device Markings / Labelling Problem | 9 |
Electro-Static Discharge | 9 |
Device Inoperable | 9 |
Difficult To Remove | 9 |
Migration | 8 |
Labelling, Instructions For Use Or Training Problem | 8 |
Manufacturing, Packaging Or Shipping Problem | 7 |
Stretched | 6 |
Noise, Audible | 6 |
Device Contaminated During Manufacture Or Shipping | 5 |
Unintended Movement | 5 |
Wireless Communication Problem | 4 |
Inadequate Instructions For Non-Healthcare Professional | 4 |
Defective Device | 4 |
Material Frayed | 4 |
Application Program Freezes, Becomes Nonfunctional | 3 |
Unauthorized Access To Computer System | 3 |
Inadequate Or Insufficient Training | 3 |
Use Of Incorrect Control Settings | 3 |
Incorrect Device Or Component Shipped | 3 |
Coil | 2 |
Unsealed Device Packaging | 2 |
Mechanical Problem | 2 |
Temperature Problem | 2 |
Degraded | 2 |
Device Stops Intermittently | 2 |
Contamination During Use | 2 |
Pin | 1 |
Compatibility Problem | 1 |
Radiofrequency Interference (RFI) | 1 |
Inadequate Instructions For Healthcare Professional | 1 |
| Total Device Problems | 20062 |
| 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 | Medtronic Neuromodulation | II | Aug-18-2014 |
| 7 | Medtronic Neuromodulation | II | Apr-29-2014 |
| 8 | St. Jude Medical, Inc. | II | Dec-10-2018 |
| 9 | St. Jude Medical, Inc. | II | Oct-17-2017 |
| 10 | St. Jude Medical, Inc. | II | Jul-07-2017 |