LEAD MODEL 302
Report
- Report Number
- 1644487-2012-03306
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- November 27, 2012
- Report Date
- November 27, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
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.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED LEAD. A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH THOSE THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS WERE OBSERVED INSIDE THE OUTER AND INNER SILICONE TUBES, IN SOME AREAS. PRODUCT ANALYSIS ON THE GENERATOR WAS COMPLETED ON (B)(6) 2013. AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PA LAB AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE EXPLANT. A RESET OF THE PULSEDISABLE BIT IN THE GENERATOR MEMORY WAS PERFORMED TO ALLOW FOR AN OUTPUT TO ONCE AGAIN BE PROVIDED BY THE GENERATOR FOR SUBSEQUENT TESTING. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.960 VOLTS SHOWS A NON IFI CONDITION. ACCORDING TO THE INTERNAL INFORMATION IN THE GENERATOR, THE IMPEDANCE VALUE WENT FROM 8389OHMS TO 10861 OHMS ON (B)(6) 2012.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2012. IT WAS REPORTED THAT THE EXPLANTED PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS BUT THEY HAVE NOT BEEN RECEIVED TO DATE.
ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 WHEN THE PROGRAMMING HISTORY DATABASE WAS REVIEWED. THE PROGRAMMING HISTORY REVEALED INFORMATION FROM THE DATE OF IMPLANT ON (B)(6) 2012. DIAGNOSTICS WERE PERFORMED ON THIS DATE WHICH SHOWED OUTPUT=OK/ LEAD IMPEDANCE = OK/ IMPEDANCE VALUE = 2472 OHMS.
THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6) 2013. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY AND HAS NOT YET BEEN COMPLETED.
ON (B)(6) 2012, IT WAS REPORTED THAT THE VNS PATIENT WAS SHOWING HIGH LEAD IMPEDANCE SO THE PATIENT WAS REFERRED FOR X-RAYS AND HER DEVICE WAS DISABLED. THE IMPEDANCE VALUE WAS NOTED TO BE APPROXIMATELY 9600 OHMS. A COPY OF THE PATIENT'S X-RAYS WERE REVIEWED BY THE MANUFACTURER. WHETHER THE LEAD CONNECTOR PIN WAS FULLY INSERTED INTO THE HEADER OF THE GENERATOR COULD NOT BE ASSESSED DUE TO THE POSITION OF THE GENERATOR IN THE PROVIDED IMAGES. A SMALL PORTION OF THE LEAD WAS SITUATED BEHIND THE GENERATOR WHICH WAS NOT ABLE TO BE ASSESSED. NO GROSS FRACTURE OR LEAD DISCONTINUITIES WERE VISUALIZED ON THE LEAD PORTION ASSESSED. BASED ON THE X-RAYS RECEIVED THERE WERE NO ANOMALIES OR LEAD DISCONTINUITIES OBSERVED THAT COULD HAVE BEEN CAUSING THE REPORTED HIGH IMPEDANCE. HOWEVER, DUE TO THE LACK OF IMAGES AVAILABLE AND DEVICE POSITIONING, THE ENTIRE LEAD BODY AND GENERATOR COULD NOT BE ASSESSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN REGARDING THE HIGH IMPEDANCE BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS, INC. | 302-20 | 009441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |