FDA Adverse Event
Injury
Summary report: N
EON MINI IPG, 16-CHANNEL RECHARGEABLE
MDR report key: 8520673
·
Received April 16, 2019
Report
- Report Number
- 1627487-2019-04144
- Event Type
- Injury
- Date Received
- April 16, 2019
- Report Date
- April 29, 2019
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 05414734402651
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED HEADACHES THAT STARTED WHEN SHE SWITCHED FROM TONIC TO BURSTDR. THIS WAS REPORTEDLY DUE TO THE THERAPY BEING INEFFECTIVE, THIS ISSUE WAS RESOLVED BY EDUCATING THE PATIENT ON BURST AND ADJUSTING THERAPY. SURGICAL INTERVENTION IS PLANNED AS BTE TRIAL WAS SUCCESSFUL.
Description of Event or Problem · 1
IT WAS REPORTED DURING FOLLOW UP THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. SURGICAL INTERVENTION ADDRESSED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313547 | EON MINI IPG, 16-CHANNEL RECHARGEABLE | IPG, SCS | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 2890999 | 05414734402651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |