FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 3192455
·
Received June 27, 2013
Report
- Report Number
- 1644487-2013-01943
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- January 1, 1995
- Report Date
- June 3, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(4) 2013 AN ARTICLE TITLED ¿VAGUS NERVE STIMULATORS IN THE TREATMENT OF EPILEPSY: OUR EXPERIENCE¿ WAS RECEIVED. REVIEW OF THE ABSTRACT REVEALED THAT AN ANALYSIS WAS CONDUCTED OF 226 VNS PATIENTS IN THEIR INSTITUTION BETWEEN 1995 AND 2008. THERE WERE 10 PROCEDURAL COMPLICATIONS INCLUDING THREE WOUND INFECTIONS. THIS REPORT HOUSES ONE OF THE THREE WOUND INFECTIONS; THE OTHER TWO ARE CAPTURED ON MFR REPORT # 1644487-2013-01942 AND MFR. REPORT # 1644487-2013-01944. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292868 | PULSE GEN MODEL UNK | GENERATOR | LYJ | CYBERONICS | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |