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 | 7495116 |
MDR Text Key | 107618715 |
Report Number | 1627487-2018-04630 |
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,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/08/2018 |
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 | 01/02/2020 |
Device Model Number | 3166 |
Device Lot Number | 6245386 |
Other Device ID Number | 05414734406109 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/20/2018
|
Initial Date FDA Received | 05/08/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/02/2018 |
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 | MODEL 3341 (X2), SCS EXTENSION; MODEL 3789, SCS IPG |
Patient Outcome(s) |
Other;
|
Patient Age | 31 YR |