FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 2072374
·
Received April 8, 2011
Report
- Report Number
- 1644487-2011-00720
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 12, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
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
A PHYSICIAN INDICATED THAT A VNS PATIENT HAD HIGH LEAD IMPEDANCE. THE PATIENT WAS BEING SEEN BY THE PHYSICIAN FOR THE FIRST TIME AND TWO SEPARATE SYSTEM DIAGNOSTIC TESTS SHOWED THE HIGH IMPEDANCE. X-RAYS WERE TAKEN BUT HAVE NOT BEEN SENT TO THE MANUFACTURER FOR REVIEW. ACCORDING TO THE PHYSICIAN'S RECORDS, THE PATIENT WAS LAST SEEN BY ANOTHER DOCTOR IN 2007, AND IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY TRAUMA OR MANIPULATION PRECEDING THE EVENT. LAST KNOWN DIAGNOSTICS IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE SHOW PROPER DEVICE FUNCTION. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 6443C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |