Brand Name | KINETRA |
Type of Device | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
Manufacturer (Section D) |
MEDTRONIC NEUROMODULATION |
800 53rd ave ne |
minneapolis MN 55421 1200 |
|
Manufacturer (Section G) |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne rcw215 |
|
minneapolis MN 55432 |
|
Manufacturer Contact |
diane
wolf
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263987
|
|
MDR Report Key | 5017573 |
MDR Text Key | 23534513 |
Report Number | 3007566237-2015-02322 |
Device Sequence Number | 1 |
Product Code |
MHY
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P960009 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Report Date |
07/25/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 7428 |
Device Catalogue Number | 7428 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/20/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|