Brand Name | EON RECHARGEABLE IPG, 16-CHANNEL |
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 | 5468123 |
MDR Text Key | 39303571 |
Report Number | 1627487-2016-00954 |
Device Sequence Number | 1 |
Product Code |
GZB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/06/2016 |
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 | 05/01/2008 |
Device Model Number | 3716 |
Device Lot Number | 55142 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/03/2016
|
Initial Date FDA Received | 02/29/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 03/09/2016 05/03/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2006 |
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 64 YR |
|
|