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 |
|
MDR Report Key | 4943062 |
MDR Text Key | 15128731 |
Report Number | 1627487-2015-12405 |
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
|
Type of Report
| Initial |
Report Date |
07/02/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/27/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/29/2016 |
Device Model Number | 3788 |
Device Lot Number | 4478344 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 07/02/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/20/2014 |
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 | 42 YR |
|
|