FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1890922
·
Received October 28, 2010
Report
- Report Number
- 1644487-2010-02422
- Event Type
- Malfunction
- Date Received
- October 28, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 28, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH.
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT SHOWED HIGH LEAD IMPEDANCE ON DIAGNOSTICS TEST. X-RAYS WERE TAKEN AND IT SHOWED A GAP IN INSULATION IN ONE OF THE LEADS. PT'S LAST GOOD DIAGNOSTICS RESULTS WERE OBTAINED ON (B)(6) 2010. NO PT MANIPULATION OR TRAUMA WAS REPORTED. X-RAYS WILL BE SENT TO MFR FOR REVIEW. PHYSICIAN STATED THAT THE PT IS ALSO HAVING AN INCREASE IN SEIZURES WHICH IS LIKELY RELATED TO THE HIGH HEAD IMPEDANCE. (B)(4) ATTEMPTS TO OBTAIN X-RAYS HAVE BEEN UNSUCCESSFUL TILL DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 200799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |