Brand Name | EON MINI IPG, 16-CHANNEL RECHARGEABLE |
Type of Device | SCS IPG |
Manufacturer (Section D) |
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
lot a interior - #2 street km 67.5 |
santana industrial park |
arecibo PR 00612 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
lot a interior - #2 street km 67.5 |
santana industrial park |
arecibo PR 00612 |
|
Manufacturer Contact |
taruna
sharma
|
6901 preston road |
plano, TX 75024
|
9725269635
|
|
MDR Report Key | 5067043 |
MDR Text Key | 25348124 |
Report Number | 1627487-2015-20516 |
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 |
Other
|
Report Date |
09/23/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/10/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2016 |
Device Model Number | 3788 |
Device Lot Number | 4623404 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/26/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 09/23/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/22/2014 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | MODEL 1192(2), SCS ANCHOR |
Patient Outcome(s) |
Other;
|