FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 104
MDR report key: 3172696
·
Received June 17, 2013
Report
- Report Number
- 1644487-2013-01796
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- August 14, 2012
- Report Date
- May 21, 2013
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS A LEAD; HOWEVER, INFORMATION INDICATES THAT NO LEAD PRODUCT WAS INVOLVED. REVIEW OF PROGRAMMING HISTORY. EVENT REPORTED BUT CONFIRMED INVALID.
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THE GENERATOR ASSOCIATED WITH THE HIGH IMPEDANCE WAS A DEMONSTRATION GENERATOR. THE DEVICE HAS NOT BEEN IMPLANTED IN A PATIENT AND IS IN THE POSSESSION OF A MANUFACTURER REPRESENTATIVE.
Description of Event or Problem · 1
AS PART OF AN INTERNAL PROGRAMMING HISTORY REVIEW IT WAS NOTED THAT THIS PATIENT HAD HIGH LEAD IMPEDANCE. GOOD FAITH ATTEMPTS WILL BE MADE FOR FURTHER DETAILS ABOUT THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272836 | PULSE GEN MODEL 104 | GENERATOR | LYJ | CYBERONICS, INC. | 104 | 200699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |