FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 3820979
·
Received May 8, 2014
Report
- Report Number
- 1627487-2014-26394
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- April 15, 2014
- Report Date
- April 18, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- 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'S IPG IS UNABLE TO COMMUNICATE WITH HER CHARGER. TROUBLESHOOTING AND A REPLACEMENT CHARGING SYSTEM WERE UNABLE TO RESOLVE THE ISSUE. IT WAS NOTED THE PT WAS ABLE TO RECHARGE APPROX A WEEK AGO. THE PT CURRENTLY HAS STIMULATION. F/U ON THIS MATTER REVEALED THE PT MUST PUT ADD'L PRESSURE ON THE ANTENNA TO ESTABLISH COMMUNICATION WITH THE CHARGING SYSTEM. IT WAS CONFIRMED THE IPG IS IMPLANTED DEEPER THAN 2CM. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279597 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 4462353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other | SCS LEAD: MODEL 3228| IMPLANT DATE: |