FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2821122
·
Received October 25, 2012
Report
- Report Number
- 1627487-2012-12384
- Event Type
- Injury
- Date Received
- October 25, 2012
- Date of Event
- October 5, 2012
- Report Date
- October 5, 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
Narratives
Additional Manufacturer Narrative · 1
RECALL NUMBERS: 1627487-07262012-002-R AND 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION. 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 EXPERIENCED LOSS OF STIMULATION. REPORTEDLY THE PHYSICIAN DID A REVISION TO RECONNECT THE LEADS TO THE IPG HEADER. FOLLOW UP DETERMINED THE PT WAS REPROGRAMMED WITH OPTIMAL COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL NEUROMODULATION | 3788 | 173228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: |