Brand Name | EON C |
Type of Device | SCS IPG |
Manufacturer (Section D) |
ST. JUDE MEDICAL ¿ NEUROMODULATION |
plano TX |
|
Manufacturer Contact |
karin
bechler
|
6901 preston rd. |
plano, TX 75024
|
9723092511
|
|
MDR Report Key | 3851424 |
MDR Text Key | 22265242 |
Report Number | 1627487-2014-10117 |
Device Sequence Number | 1 |
Product Code |
GZB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
05/02/2014 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/01/2015 |
Device Model Number | 3688 |
Device Lot Number | 3915180 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/02/2014 |
Initial Date FDA Received | 05/22/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/01/2013 |
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 | SCS LEAD, MODEL: 3228,; IMPLANT DATE: |
Patient Age | 80 YR |
|
|