LEAD MODEL 302
Report
- Report Number
- 1644487-2013-00547
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 30, 2013
- Report Date
- February 1, 2013
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
EVENT DESCRIPTION, CORRECTED DATA: DEVICE MANUFACTURING RECORDS WERE REVIEWED, BUT NOT REPORTED ON THE PREVIOUS MDR. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION.
ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL A LEAD BREAK. DEVICE FAILURE IS POSSIBLE IN THE PORTION OF THE LEAD NOT RETURNED FOR ANALYSIS, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
THE PATIENT HAD FULL REVISION SURGERY ON (B)(6) 2013. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR PRODUCT RETURN. IT WAS NOTED THAT THERE WAS A BREAK IN THE OR. AN OPENING WAS SEEN IN TUBING WITH BODY TISSUE GOING INTO THE LEAD BODY CLOSE TO GENERATOR CAN. PIN REINSERTION WAS PERFORMED AND STILL HIGH LEAD IMPEDANCE. PROPHYLACTIC REPLACEMENT OF THEIR GENERATOR. JUST THAT PORTION OF LEAD AND GENERATOR SAVED AND SENT TO PATHOLOGY.
DEVICE MANUFACTURING RECORDS WERE REVIEWED WHICH INDICATE THAT THE DEVICE PASSED ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.
IT WAS REPORTED BY (B)(6) THAT THEY WERE FOLLOWING UP ON A VNS PATIENT. DIAGNOSTICS WERE PERFORMED AND SYSTEM DIAGNOSTIC TESTING SHOWED OUTPUT CURRENT LIMIT WITH HIGH LEAD IMPEDANCE. EXACT RESULTS NOT KNOWN. THE LAST TIME THE PATIENT'S VNS WAS CHECKED WAS (B)(6) 2011. THE PATIENT DENIES ANY FALLS OR TRAUMA BUT TYPICALLY HAS NOCTURNAL SEIZURES SO SHE COULD HAVE AND BEEN UNAWARE OF IT. HER DEVICE WAS NOT PROGRAMMED OFF BECAUSE SHE HAS BEEN DOING RELATIVELY WELL AND HE DID NOT WANT HER TO GO WITHOUT THERAPY. X-RAYS WERE ORDERED BUT UNKNOWN IF THEY HAVE BEEN DONE YET. THE PATIENT'S CURRENT SETTINGS ARE 2.5MA /30 SF / 250 PW / 30 SECONDS ON TIME / 5 MINUTES OFF TIME. THE PATIENT IS CURRENTLY STABLE WITH NO CHANGE IN THEIR SEIZURE STATUS. NO SURGERY IS PLANNED AT THIS TIME.
THE EXPLANTED PRODUCTS WERE RETURNED FOR ANALYSIS. THE PULSE GENERATOR WAS EXPLANTED/RETURNED DUE TO ¿PROPHYLACTIC REPLACEMENT¿. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS AND THE REPORTED ¿MECHANICAL PROBLEM / PUNCTURED INSULATION¿ ALLEGATION WAS VERIFIED. A LEAD BREAK WAS NOT CONFIRMED. NOTE THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE REPORT INDICATED THAT DURING REVISION SURGERY THERE WAS AN OPENING IN THE TUBING WITH BODY TISSUE GOING INTO THE LEAD BODY CLOSE TO THE GENERATOR CAN. IT APPEARS THIS PORTION WAS NOT RETURNED, SINCE BODY TISSUE WAS NOT OBSERVED ON THE RETURNED LEAD PORTIONS. DURING THE VISUAL ANALYSIS AN INCISION MARK WAS OBSERVED ON THE BODY OF THE RETURNED LEAD ASSEMBLY. THE INCISION MARK PENETRATED ONE SIDE OF THE OUTER SILICONE TUBING. THE INCISION MARK FOUND ON THE OUTER SILICONE TUBING AND THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. FOR THE OBSERVED INNER TUBING FLUID REMNANTS, THERE WAS NO OBVIOUS PATH FOR FLUID INGRESS OTHER THAN THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED EXCEPT FOR THE HALF SET OF SETSCREW MARKS FOUND NEAR THE END OF THE CONNECTOR PIN INDICATING THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE CAVITY OF THE GENERATOR AT ONE TIME. THE MARKS ARE EVIDENCE OF A POTENTIALLY INSUFFICIENT MECHANICAL CONTACT BETWEEN CONDUCTIVE SURFACES OF THE GENERATOR AND CONNECTOR RING, RESULTING IN A SUSPECT ELECTRICAL CONNECTION TO THE LEAD. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST A DISCONTINUITY IN THE RETURNED PORTIONS OF THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE STATED ALLEGATIONS. INCOMPLETE INSERTION OF THE CONNECTOR PIN MAY HAVE BEEN A POTENTIAL CAUSE FOR THE OBSERVED HIGH IMPEDANCE CONDITION DURING THE IMPLANT OF THIS LEAD. SINCE A PORTION OF THE LEAD WAS NOT RETURNED THAT WAS REPORTED TO HAVE BODY TISSUE IN IT IS UNKNOWN IF THIS WAS ALSO A CONTRIBUTING FACTOR TO THEIR HIGH IMPEDANCE. THE LEAD PIN NOT BEING FULLY INSERTED WILL BE ADDRESSED IN MEDWATCH REPORT NUMBER: 1644487-2013-01622.
THE PATIENT IS BEING REFERRED FOR SURGERY NO DATE SET AT THIS TIME. X-RAYS HAVE NOT BEEN PROVIDED TO THE MANUFACTURE FOR REVIEW. THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2013 AND HIGH IMPEDANCE STILL PRESENT. THEIR DEVICE HAS NOT BEEN PROGRAMMED OFF AS THEIR PHYSICIAN WANTS TO LEAVE IT PROGRAMMED ON. THE PATIENT STILL FEELS BENEFIT FROM ANY THERAPY THEY ARE GETTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88456 | LEAD MODEL 302 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-30 | 2344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |