FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 100
MDR report key: 1041280
·
Received May 9, 2008
Report
- Report Number
- 1644487-2008-01114
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 11, 2008
- Report Date
- April 11, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A DEVICE MALFUNCTION CANNOT BE RULED OUT, BUT EVENT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THEY HAD THEIR VNS EXPLANTED FOR LACK OF EFFICACY. FURTHER INFORMATION WAS ATTAINED FROM THE PATIENT'S TREATING PHYSICIAN THAT THE PATIENT "PROBABLY DID NOT" HAVE EFFICACY. SETTING CHANGES WERE ATTEMPTED TO GAIN EFFICACY. NO DEVICE DIAGNOSTICS WERE PROVIDED BY SITE TO RULE OUT A DEVICE MALFUNCTION. THE DEVICE WAS DISABLED IN 2001. THE EXPLANTED GENERATOR IS AT MANUFACTURER PENDING COMPLETION OF PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 100 | LYJ | CYBERONICS, INC. | 100 | 23672C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |