FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 2903063 · Received January 3, 2013

Report

Report Number
1627487-2013-15006
Event Type
Injury
Date Received
January 3, 2013
Date of Event
December 6, 2012
Report Date
December 6, 2012
Manufacturer
ST. JUDE MEDICAL - NEUROMODULATION
Product Code
LGW
PMA / PMN Number
P010032
Removal / Correction Number
1627487-05242011-002-R
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
NOT APPLICABLE

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2053 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2849290

Patients

Seq Age Sex Outcome Treatment
1 60 YR Required Intervention IMPLANT DATE: | IMPLANT DATE: | IMPLANT DATE: | SCS EXTENSION: MODEL 3383 (2)| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3219