Brand Name | OCTRODE |
Type of Device | SCS LEAD |
Manufacturer (Section D) |
ST JUDE MEDICAL, NEUROMODULATION |
plano TX |
|
Manufacturer Contact |
benjyna
obasuyi
|
6901 preston rd. |
plano, TX 75024
|
9725264659
|
|
MDR Report Key | 4041264 |
MDR Text Key | 4866607 |
Report Number | 1627487-2014-25567 |
Device Sequence Number | 1 |
Product Code |
GZB
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
07/29/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/20/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/01/2014 |
Device Model Number | 3183 |
Device Lot Number | 3799314 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 07/29/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/01/2012 |
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 |
Treatment | IMPLANT DATE:; SCS EXTENSIONS: MODEL 3386 (2), |
Patient Outcome(s) |
Other;
|
Patient Age | 58 YR |
Patient Weight | 68 |
|
|