FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 2946283
·
Received February 6, 2013
Report
- Report Number
- 1644487-2013-00307
- Event Type
- Injury
- Date Received
- February 6, 2013
- Date of Event
- October 4, 2003
- Report Date
- January 14, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT AND A MASTECTOMY AT THE SAME TIME. PREVIOUSLY, IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED BREAST CANCER WAS DECIDING ON TREATMENT OPTIONS. RIGHT SIDED GENERATOR PLACEMENT WAS DISCUSSED. IT IS UNKNOWN WHY THE GENERATOR WAS REPLACED OR IF THE PHYSICIAN BELIEVES IF THE BREAST CANCER IS RELATED TO VNS THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51139 | PULSE GEN MODEL 101 | GENERATOR | LYJ | CYBERONICS INC | 101 | 6100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Life Threatening| O| R |