Brand Name | EON MINI |
Type of Device | SCS IPG |
Manufacturer (Section D) |
ST. JUDE MEDICAL - NEUROMODULATION |
plano TX |
|
Manufacturer Contact |
connie
timmons
|
6901 preston rd. |
plano, TX 75024
|
9723098054
|
|
MDR Report Key | 4143079 |
MDR Text Key | 4933677 |
Report Number | 1627487-2014-12640 |
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
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
08/30/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/23/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/01/2013 |
Device Model Number | 3788 |
Device Lot Number | 3389156 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/30/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/01/2011 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 1627487-07262012-002-R |
Patient Sequence Number | 1 |
Treatment | IMPLANT DATE:; SCS ANCHORS, MODEL: 1192; SCS LEADS, MODEL: 3186; IMPLANT DATE: |
Patient Outcome(s) |
Other;
|
Patient Age | 70 YR |
|
|