FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNK
MDR report key: 2191583
·
Received July 20, 2011
Report
- Report Number
- 1644487-2011-01644
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 22, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED BY A NURSE THAT HIGH LEAD (7/LIMIT/HIGH) IMPEDANCE WAS RECEIVED UPON INTERROGATION OF A PT'S GENERATOR. ACCORDING TO THE REPORTING NURSE, THE PT HAS HAD A BAD MORNING OF SEIZURES AND THE HISTORY MAY BE UNCLEAR; HOWEVER, THE PT HAS BEEN USING CLOBAZAM IN RECENT DAYS. THE TREATING NURSE INDICATED THAT SHE REDUCED THE PT SETTINGS AND REFERRED TO PT FOR X-RAYS. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO FROM THE TREATING NURSE HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNK | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |