FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 3012187
·
Received March 13, 2013
Report
- Report Number
- 1627487-2013-13285
- Event Type
- Injury
- Date Received
- March 13, 2013
- Date of Event
- February 20, 2013
- Report Date
- February 20, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-07262012-002-R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION 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
DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2013-13286. IT WAS REPORTED THE PT FEELS WHAT HE DESCRIBES AS A "SHOCK" ALL OVER HIS BODY WHEN HE TURNS THE PROGRAMMER ON. IT WAS NOTED THE "SHOCKS" ARE SIMULTANEOUS WITH THE BEEPS THE PROGRAMMER MAKES WHEN IT'S COMMUNICATING WITH THE IPG. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. FOLLOW-UP PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106214 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3498001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |