FDA Adverse Event
Injury
Summary report: N
EON 16-CHANNEL IPG
MDR report key: 1936247
·
Received December 14, 2010
Report
- Report Number
- 1627487-2010-03921
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- November 15, 2010
- Report Date
- November 15, 2010
- Manufacturer
- SJM NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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
DEVICE 1 OF 3. SEE MFR REPORT #S 1627487-2010-03948 AND 1627487-2010-03950. THE PT RECEIVED HER SCS SYS ON (B)(6) 2006. IT WAS REPORTED THAT THE PT HAD BEEN EXPERIENCING HEADACHES EVER SINCE THE SYS WAS IMPLANTED. SHE HAS BEEN REPROGRAMMED SEVERAL TIMES BUT THE HEADACHES PERSIST. THE SYS WAS EXPLANTED AND RETURNED TO THE MFR FOR EVAL ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON 16-CHANNEL IPG | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | SJM NEUROMODULATION DIVISION | 3716 | 63624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |