Brand Name | SOLETRA |
Type of Device | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
Manufacturer (Section D) |
MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
ceiba norte industrial park, r |
juncos PR 00777 |
|
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 | 4471012 |
MDR Text Key | 5497049 |
Report Number | 3004209178-2015-01519 |
Device Sequence Number | 1 |
Product Code |
MHY
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P960009 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/13/2015 |
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 Expiration Date | 05/14/2009 |
Device Model Number | 7426 |
Device Catalogue Number | 7426 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/13/2015 |
Initial Date FDA Received | 01/30/2015 |
Date Device Manufactured | 11/14/2007 |
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) |
Required Intervention;
|
Patient Age | 00047 YR |
|
|