Brand Name | QUATTRODE LEAD WIDE SPACED, 60 CM |
Type of Device | SCS LEAD |
Manufacturer (Section D) |
ST. JUDE MEDICAL - NEUROMODULATION |
6901 preston rd |
plano TX 75024 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL - NEUROMODULATION |
6901 preston rd |
|
plano TX 75024 |
|
MDR Report Key | 4582939 |
MDR Text Key | 5454494 |
Report Number | 1627487-2015-12110 |
Device Sequence Number | 1 |
Product Code |
GZB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K072462 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/13/2015 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/28/2015 |
Device Model Number | 3166 |
Device Lot Number | 3910822 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/13/2015
|
Initial Date FDA Received | 03/09/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/14/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | MODEL 3225, SCS LEAD; MODEL 3789, SCS IPG; MODEL 3343, SCS EXTENSION |
Patient Outcome(s) |
Other;
|
Patient Age | 47 YR |
|
|