LEAD MODEL 302
Report
- Report Number
- 1644487-2011-00206
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 11, 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
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
AGE AT TIME OF EVENT, CORRECTED DATA: THE SUPPLEMENTAL MDR #2 INADVERTENTLY DID NOT UPDATE THE PATIENT'S AGE WITH THE BEST ESTIMATE FOR THE EVENT DATE AS 2010. DATE OF EVENT, CORRECTED DATA: THE SUPPLEMENTAL REPORT #2 INADVERTENTLY REPORTED THE DATE OF EVENT INCORRECTLY. WITH THE PROVIDED INFORMATION, THE BEST ESTIMATE FOR THE EVENT DATE IS 2010. DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE SUPPLEMENTAL REPORT #2 INADVERTENTLY DID NOT INCLUDE THIS INFORMATION. THE DATE OF IMPEDANCE CHANGE WAS INITIALLY MISINTERPRETED. THE EXACT CHANGE TO HIGH IMPEDANCE IS STILL UNKNOWN.
DATE OF EVENT, CORRECTED DATA: THE ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE HIGH IMPEDANCE FIRST OCCURRED AROUND (B)(6) 2010. ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
THE SUPPLEMENTAL MDR #3 INADVERTENTLY CHANGED THE PATIENT'S AGE WITH REGARDS TO THE INCORRECT EVENT DATE.
THE PATIENT HAS BEEN REFERRED FOR FULL REVISION SURGERY, PER THE SURGEON'S OFFICE. HOWEVER, IT HAS NOT OCCURRED TO DATE.
REVIEW OF THE IN-HOUSE DATABASE REVEALED HISTORY REVEALED THAT THE HIGH IMPEDANCE WAS FIRST OBSERVED ON (B)(4) 2011.
THE PATIENT'S EXPLANTED GENERATOR AND LEAD WERE RECEIVED BY THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6) 2012. IT WAS LATER INDICATED THAT THE FULL REVISION SURGERY OCCURRED ON (B)(6) 2012. THE RETURN PRODUCT FORM AND IMPLANT CARD CONFIRMED THE DATE OF SURGERY. THE IMPLANT CARD REPORTED THE REASON FOR REPLACEMENT AS LEAD DISCONTINUITY. ANALYSIS OF BOTH THE GENERATOR AND LEAD WERE COMPLETED. THE REPORTED HIGH IMPEDANCE NOT VERIFIED WITHIN THE RETURNED LEAD PORTION. NOTE THAT SINCE A PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. SETSCREW MARKS WERE SEEN ON THE CONNECTOR PIN, PROVIDING EVIDENCE THAT PROPER CONTACT BETWEEN THE SETSCREW AND THE LEAD PIN EXISTED AT LEAST ONCE. ADDITIONALLY, ELECTRICAL TESTS SHOWED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. REVIEW OF THE GENERATOR DECODER SPREADSHEET REVEALS THAT THE ESTIMATED CHANGE IN IMPEDANCE TO HIGH IMPEDANCE OCCURRED APPROXIMATELY ON (B)(6) 2010.
REVIEW OF THE GENERATOR DECODER SPREADSHEET REVEALS THAT THE ESTIMATED CHANGE IN IMPEDANCE OCCURRED APPROXIMATELY ON (B)(6) 2010. HOWEVER, PREVIOUS TO THIS DATE, THE IMPEDANCE WAS STILL HIGH 8228 OHMS. IT CHANGED TO 12641 OHMS ON (B)(6) 2010. THEREFORE, THE EVENT DATE WAS CHANGED TO 2010.
IT WAS REPORTED BY A NEUROLOGIST THAT HIGH LEAD IMPEDANCE WAS ENCOUNTERED WHILE PERFORMING SYSTEM DIAGNOSTICS (>10000 OHMS) ON A VNS PT. THE NEUROLOGIST INDICATED THAT THE PT STILL FEELS STIMULATION, IS NOT HAVING AN INCREASE IN SEIZURES, AND DENIES ANY TRAUMA TO THE AREA. THE PT'S DEVICE WAS DISABLED DUE TO THE HIGH IMPEDANCE AND THE LAST KNOWN GOOD DIAGNOSTICS WERE 6 MONTHS PRIOR TO THE VISIT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 2491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |