Brand Name | EON MINI IPG, 16-CHANNEL RECHARGEABLE |
Type of Device | SCS IPG |
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 | 7029093 |
MDR Text Key | 91943231 |
Report Number | 1627487-2017-07242 |
Device Sequence Number | 1 |
Product Code |
LGW
|
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,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/25/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/28/2017 |
Device Model Number | 3788 |
Device Lot Number | 4945340 |
Other Device ID Number | 05414734402651 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/10/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/25/2017 |
Initial Date FDA Received | 11/14/2017 |
Supplement Dates Manufacturer Received | 03/23/2018 04/27/2018
|
Supplement Dates FDA Received | 04/16/2018 05/25/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/19/2015 |
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 3246 SCS LEADS ( X 2) |
Patient Outcome(s) |
Other;
|
Patient Age | 51 YR |