| Device |
stimulator, electrical, implanted, for parkinsonian tremor |
| Product Code | MHY |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
3
|
7
|
18
|
28
|
31
|
25
|
4
|
|
| Device Problems |
| High impedance |
797 |
| No Known Device Problem |
787 |
| Unknown (for use when the device problem is not known) |
578 |
| Device remains implanted |
530 |
| Device operates differently than expected |
510 |
| Replace |
461 |
| Inappropriate shock |
360 |
| Explanted |
357 |
| No Information |
351 |
| Electro-magnetic interference (EMI) |
265 |
| Other (for use when an appropriate device code cannot be identified) |
263 |
| Implant, reprogramming of |
231 |
| Low impedance |
216 |
| Migration of device or device component |
193 |
| Fracture |
182 |
| Premature discharge of battery |
179 |
| Bent |
158 |
| Break |
123 |
| Loss of power |
121 |
| Intermittent continuity |
110 |
| Lead(s), breakage of |
106 |
| Device stops intermittently |
95 |
| Low battery |
86 |
| Wire(s), breakage of |
80 |
| Device operational issue |
71 |
| Impedance issue |
70 |
| Unit inactivated |
64 |
| Implant, removal of |
64 |
| Malposition of device |
61 |
| Device inoperable |
60 |
| Electronic property issue |
59 |
| Malfunction |
50 |
| Electro-magnetic interference (EMI), compatibility/incompatibility |
48 |
| Out-of-box failure |
47 |
| Battery issue |
45 |
| Kinked |
44 |
| Battery failure |
44 |
| Shock, electrical |
37 |
| Material erosion |
37 |
| Suspect EMI |
36 |
| Circuit breaker tripped |
35 |
| Improper or incorrect procedure or method |
35 |
| Connection issue |
34 |
| Device, or device fragments remain in patient |
33 |
| Device remains activated |
32 |
| Implant, repositioning of |
31 |
| Circuit Failure |
31 |
| Device Issue |
31 |
| Positioning Issue |
29 |
| Electrical shorting |
27 |
| Component(s), broken |
25 |
| Device displays error message |
24 |
| No telemetry |
23 |
| Lead(s), fracture of |
22 |
| Tears, rips, holes in device, device material |
21 |
| Loose or intermittent connection |
21 |
| Electromagnetic compatibility issue |
20 |
| Dislodged |
18 |
| Failure to interrogate |
18 |
| Disconnection |
18 |
| Communication or transmission issue |
17 |
| Physical property issue |
16 |
| Dislodged or dislocated |
16 |
| Misplacement |
16 |
| Hybrid failure |
15 |
| Difficult to Program or Calibrate |
14 |
| Fitting problem |
14 |
| Performance |
14 |
| Electrode(s), fracture of |
14 |
| Electrode contact(s), problem with |
13 |
| Loss of or failure to bond |
13 |
| Repair |
12 |
| Magnetic interference |
12 |
| Difficult to position |
12 |
| Unexpected therapeutic results |
12 |
| Device damaged prior to use |
12 |
| Stretched |
11 |
| Failure, intermittent |
10 |
| Material twisted |
10 |
| Misconnection |
10 |
| Program, failure to |
10 |
| Programming issue |
10 |
| Defective component |
9 |
| Low battery impedance |
9 |
| Unintended movement |
9 |
| Insulation degradation |
9 |
| Failure to align |
8 |
| Buckled material |
8 |
| Charging issue |
8 |
| Material frayed |
8 |
| Device-device incompatibility |
7 |
| Shelf life exceeded |
7 |
| Material fragmentation |
7 |
| Slippage of device or device component |
7 |
| Pocket stimulation |
7 |
| Unable to interrogate |
7 |
| Failure to charge |
6 |
| Telemetry discrepancy |
6 |
| Computer software issue |
6 |
| Tipover |
6 |
| Total Device Problems |
8921 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
| Class II |
1 |
2 |
0 |
0 |
0 |
1 |
1 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
