FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1063630
·
Received June 20, 2008
Report
- Report Number
- 1644487-2008-01420
- Event Type
- Malfunction
- Date Received
- June 20, 2008
- Date of Event
- May 20, 2008
- Report Date
- May 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD CODE: MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. NO GROSS LEAD DISCONTINUITIES VISUALIZED. CONCLUSION: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT PATIENT RECEIVED HIGH LEAD IMPEDANCE RESULTS ON SYSTEM DIAGNOSTICS. X-RAYS WERE REVIEWED BY MANUFACTURER. NO OBVIOUS CAUSE FOR THE HIGH IMPEDANCE WAS VISUALIZED. PATIENT HAD EXPLORATORY SURGERY. SURGEON REPORTED PATIENT HAD DEVELOPED A SIGNIFICANT AMOUNT OF SCAR TISSUE WHICH CAUSED THE LEAD TO BE "PULLED OUT OF PLACE". THE PHYSICIAN DISSECTED THE SCAR TISSUE AND PLACED A NEW LEAD WITHOUT INCIDENT. EXPLANTED LEAD IS PENDING PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 6181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |