FDA Adverse Event
Injury
Summary report: N
EON MINI IPG, 16-CHANNEL RECHARGEABLE
MDR report key: 2251170
·
Received September 12, 2011
Report
- Report Number
- 1627487-2011-04175
- Event Type
- Injury
- Date Received
- September 12, 2011
- Date of Event
- August 15, 2011
- Report Date
- August 15, 2011
- 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
THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2011. THE PT REPORTED INTERMITTENT HEAT FROM THE IPG SITE; HE STATED THE SKIN FELT WARM TO THE TOUCH. THE PT REPORTED THE ISSUE WAS NOT DEPENDENT ON WHEN HE WAS CHARGING OR COMMUNICATING WITH HIS PROGRAMMER. THE PT WILL FOLLOW UP WITH HIS PHYSICIAN WITH THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI IPG, 16-CHANNEL RECHARGEABLE | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3269344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention | IMPLANT DATE:| SCS LEAD: MODEL 3228 |