FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 3032406
·
Received March 29, 2013
Report
- Report Number
- 1627487-2013-12407
- Event Type
- Injury
- Date Received
- March 29, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 6, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCES RANDOM BURNING AND THROBBING SENSATION AT THE IPG SITE. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PHYSICIAN PLANS SURGICAL INTERVENTION TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130147 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3719245 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | IMPLANT DATE:| SCS LEAD: MODEL 1194 (2)| SCS LEAD: MODEL 3228| IMPLANT DATE: |