Brand Name | SOLETRA |
Type of Device | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
Manufacturer (Section D) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
humacao PR 00792 |
|
Manufacturer (Section G) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
|
humacao PR 00792 |
|
Manufacturer Contact |
lisa
woodward clark
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263920
|
|
MDR Report Key | 7672089 |
MDR Text Key | 113642514 |
Report Number | 1030489-2018-00967 |
Device Sequence Number | 1 |
Product Code |
MHY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P960009 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/02/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/14/2003 |
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 |
07/03/2018 |
Initial Date FDA Received | 07/09/2018 |
Supplement Dates Manufacturer Received | 08/08/2018
|
Supplement Dates FDA Received | 10/02/2018
|
Date Device Manufactured | 01/22/2002 |
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 |
|
|