Brand Name | QUATTRODE LEAD WIDE SPACED, 60 CM |
Type of Device | SCS LEAD |
Manufacturer (Section D) |
ST. JUDE MEDICAL - NEUROMODULATION |
plano TX 75024 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL - NEUROMODULATION |
6901 preston rd |
|
plano TX 75024 |
|
Manufacturer Contact |
|
MDR Report Key | 4566117 |
MDR Text Key | 5547774 |
Report Number | 1627487-2015-20147 |
Device Sequence Number | 1 |
Product Code |
GZF
|
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 |
02/11/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/03/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2012 |
Device Model Number | 3166 |
Device Lot Number | 3071548 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/11/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/24/2010 |
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 3788, SCS IPG; MODEL 3343, SCS EXTENSION |
Patient Outcome(s) |
Other;
|
Patient Age | 86 YR |
|
|