FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1003311
·
Received February 27, 2008
Report
- Report Number
- 1644487-2008-00463
- Event Type
- Malfunction
- Date Received
- February 27, 2008
- Date of Event
- January 25, 2008
- Report Date
- January 30, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THE PATIENT HAD THE VNS THERAPY SYSTEM EXPLANTED. AT THE TIME OF THE INITIAL REPORT THE REASON FOR THE EXPLANT WAS UNKNOWN. THE EXPLANTED PRODUCTS HAVE BEEN RETURNED TO THE MANUFACTURER AND ARE PENDING PRODUCT ANALYSIS. THE RETURN PRODUCT FORM RETURNED WITH THE EXPLANTED PRODUCTS LISTED THE REASON FOR THE EXPLANT AS "OTHER-NON-FUNCTIONING". THE FORM DID NOT SPECIFY IF THE GENERATOR OR THE LEAD WAS "NON-FUNCTIONING". GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |