| Device Type ID | 2851 |
| Device Name | Pump, Infusion, Implanted, Programmable |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LKK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2851 |
| Device | Pump, Infusion, Implanted, Programmable |
| Product Code | LKK |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 6351 |
Device Operates Differently Than Expected | 4020 |
Pumping Stopped | 2733 |
Device Displays Incorrect Message | 2416 |
Material Integrity Problem | 1727 |
Insufficient Flow Or Under Infusion | 1723 |
Volume Accuracy Problem | 1692 |
Aspiration Issue | 1495 |
Failure To Service | 1214 |
Intermittent Infusion | 1190 |
Unstable | 1142 |
Migration Or Expulsion Of Device | 1047 |
Improper Or Incorrect Procedure Or Method | 957 |
Inappropriate Or Unexpected Reset | 748 |
Insufficient Information | 730 |
Filling Problem | 714 |
Occlusion Within Device | 605 |
Electromagnetic Interference | 590 |
Fluid Leak | 570 |
Excess Flow Or Over-Infusion | 548 |
Kinked | 516 |
Infusion Or Flow Problem | 500 |
Use Of Device Problem | 346 |
Disconnection | 310 |
No Audible Alarm | 309 |
Device Or Device Fragments Location Unknown | 297 |
Obstruction Of Flow | 294 |
Human-Device Interface Problem | 242 |
Device Alarm System | 236 |
Nonstandard Device | 219 |
Premature Elective Replacement Indicator | 199 |
Battery Problem | 171 |
Positioning Problem | 149 |
Mechanical Jam | 128 |
Device Ingredient Or Reagent Problem | 128 |
Failure To Disconnect | 124 |
Data Problem | 118 |
Communication Or Transmission Problem | 115 |
Protective Measures Problem | 110 |
Malposition Of Device | 107 |
Failure To Interrogate | 87 |
Appropriate Term/Code Not Available | 73 |
Difficult To Interrogate | 66 |
Application Program Problem | 65 |
Difficult To Advance | 60 |
Improper Flow Or Infusion | 58 |
Connection Problem | 56 |
Device Operational Issue | 54 |
Activation Failure Including Expansion Failures | 53 |
Device Issue | 50 |
Inadequacy Of Device Shape And/or Size | 50 |
Temperature Problem | 42 |
Torn Material | 40 |
Premature End-of-Life Indicator | 32 |
Activation, Positioning Or Separation Problem | 28 |
Vibration | 26 |
Shelf Life Exceeded | 26 |
Catheter | 22 |
Patient Device Interaction Problem | 21 |
Noise, Audible | 17 |
Misconnection | 17 |
Increase In Pressure | 14 |
Environmental Compatibility Problem | 14 |
Decrease In Pressure | 14 |
Material Puncture / Hole | 13 |
Overfill | 13 |
Leak / Splash | 11 |
Display Or Visual Feedback Problem | 11 |
Component Missing | 10 |
Particulates | 9 |
Material Split, Cut Or Torn | 9 |
Unintended Electrical Shock | 9 |
Material Deformation | 9 |
Pump | 8 |
Inadequate Or Insufficient Training | 8 |
Difficult To Position | 8 |
Missing Value Reason | 8 |
Contamination During Use | 8 |
Ambient Temperature Problem | 7 |
Changes In Ambient Temperature In Device Environment | 7 |
Off-Label Use | 7 |
Pumping Problem | 7 |
Material Too Rigid Or Stiff | 6 |
Device Damaged By Another Device | 6 |
Detachment Of Device Component | 6 |
Defective Device | 6 |
Mechanical Problem | 6 |
Difficult To Insert | 6 |
Low Battery | 6 |
Bent | 6 |
Extrusion | 6 |
Difficult Or Delayed Positioning | 5 |
Device Handling Problem | 5 |
Separation Failure | 4 |
Device Markings / Labelling Problem | 4 |
Labelling, Instructions For Use Or Training Problem | 4 |
Break | 4 |
No Flow | 4 |
High Impedance | 3 |
Coiled | 3 |
| Total Device Problems | 38067 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Codman & Shurtleff, Inc. | II | May-28-2015 |
| 2 | Codman & Shurtleff, Inc. | II | May-09-2014 |
| 3 | Flowonix Medical, Inc. | II | Jun-19-2017 |
| 4 | Medtronic Neuromodulation | II | Mar-03-2018 |
| 5 | Medtronic Neuromodulation | III | Feb-06-2018 |
| 6 | Medtronic Neuromodulation | II | Mar-29-2017 |
| 7 | Medtronic Neuromodulation | I | Dec-19-2016 |
| 8 | Medtronic Neuromodulation | II | Mar-29-2016 |
| 9 | Medtronic Neuromodulation | II | May-28-2015 |
| 10 | Medtronic Neuromodulation | II | Aug-08-2014 |
| 11 | Medtronic Neuromodulation | II | Jun-04-2014 |
| 12 | Medtronic Neuromodulation | II | May-08-2014 |
| 13 | Medtronic Neuromodulation | II | May-08-2014 |