FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2472909
·
Received February 29, 2012
Report
- Report Number
- 1644487-2012-00548
- Event Type
- Malfunction
- Date Received
- February 29, 2012
- Date of Event
- January 25, 2012
- Report Date
- February 1, 2012
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED A PATENT HAD HIGH LEAD IMPEDANCE WITH VNS DIAGNOSTICS TESTING. THE VNS WAS NOT AT END OF SERVICE. THE REPORTER WAS ADVISED TO DISABLE THE VNS DUE TO THE HIGH LEAD IMPEDANCE. THE PATIENT HAS BEEN REFERRED FOR POSSIBLE SURGERY. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.
Description of Event or Problem · 1
REPORTER INDICATED THAT HE INADVERTENTLY REPORTED THE INCORRECT PATIENT AS HAVING HIGH LEAD IMPEDANCE. THE CORRECT PATIENT'S VNS HIGH LEAD IMPEDANCE WAS PREVIOUSLY REPORTED VIA MDR REPORT #1644487-2012-00480.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LEAD MODEL 302 | MUZ | CYBERONICS INC | 302-20 | 1651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |