BIPOL LEAD MODEL 300
Report
- Report Number
- 1644487-2011-02249
- Event Type
- Malfunction
- Date Received
- September 23, 2011
- Date of Event
- May 5, 2011
- Report Date
- August 30, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHEN IT WAS DISCOVERED THAT THE VNS PATIENT HAD BEEN SCHEDULED FOR SURGERY ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT HAD DEVELOPED A URINARY TRACT INFECTION THE NIGHT BEFORE SO WAS NOT CLEARED FOR SURGERY. THE PATIENT WAS THEN RE-SCHEDULED FOR (B)(6) 2012 BUT THIS WAS CANCELLED AS WELL AS THE SURGEON DID NOT KNOW IT WAS GOING TO BE FULL REVISION AND THEREFORE DID NOT BOOK ENOUGH OPERATING ROOM TIME FOR A FULL REVISION. THE PATIENT WAS INTERROGATED ON (B)(6) 2012 AND THE PATIENT' SETTINGS WERE OUTPUT=1.25MA/FREQUENCY=25HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=1.50MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=500USEC. A NORMAL MODE DIAGNOSTICS TEST WAS PERFORMED WHICH SHOWED OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7/ERI=NO. THE PATIENT WAS THEN DISABLED TO A NORMAL MODE AND MAGNET MODE OUTPUT OF 0MA DUE TO THE HIGH IMPEDANCE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN THE PHYSICIAN REPORTED THE HIGH IMPEDANCE WAS FIRST OBSERVED ON (B)(6) 2011 AND THAT OTHER THAN IN (B)(6) 2011 THE PATIENT HAD NOT BEEN SEEN SINCE 2009. X-RAYS WERE TAKEN IN (B)(6) 2011 BUT THE PHYSICIAN REPORTED THAT THEY PROVIDED NO INFORMATION; THE X-RAYS WERE NOT SENT TO THE MANUFACTURER FOR REVIEW. THE PHYSICIAN STATED THAT HE DOES NOT KNOW IF ANY PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED.
ON (B)(6) 2011, A VNS TREATING PHYSICIAN REPORTED THAT THE VNS PATIENT HAD HIGH IMPEDANCE ON (B)(6) 2011. A SYSTEM AND NORMAL MODE DIAGNOSTIC TEST THAT DAY SHOWED OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7. ON (B)(6) 2011, THE SYSTEM AND NORMAL MODE DIAGNOSTICS AGAIN SHOWED OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7. THE PATIENT'S SETTINGS ON (B)(6) 2011 WERE OUTPUT=1.25MA/FREQUENCY=25HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=1.5MA/MAGNET OUTPUT=500USEC/MAGNET ON TIME=60SEC. THE PATIENT'S NEXT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN SINCE THE PATIENT'S APPOINTMENT ON (B)(6) 2011 BUT NO FURTHER INFORMATION WAS RECEIVED TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED. WHEN FURTHER INFORMATION IS RECEIVED IT WILL BE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. PRODUCT ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(6) 2012. A PORTION OF THE LEAD ELECTRODES WERE NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. PRODUCT ANALYSIS FOUND THAT THE LEAD COIL APPEARED TO BE BROKEN APPROXIMATELY 3MM AND 5MM FROM THE END OF THE ELECTRODE BIFURCATION. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE COIL BREAK FOUND AT 3MM AND IDENTIFIED THE AREA ON TWO OF THE COIL STRANDS AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (FATIGUE APPEARANCE) WITH MECHANICAL DAMAGE AN NO PITTING. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE COIL BREAK FOUND AT 5MM AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. LOW MAGNIFICATION SEM ANALYSIS OF THE QUADFILAR COIL SHOWS CHARACTERISTICS TYPICAL OF A LEAD DISCONTINUITY WHICH MAY INCLUDE: MATERIAL FRACTURE, ROUGH OR PITTED SURFACE, THINNED MATERIAL THICKNESS, ELECTRO-ETCHING OR MATERIAL DISSOLUTION. THE INCISION AND SLICE MARKS FOUND ON THE OUTER SILICONE TUBING, 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. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITIES, THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED. THE RESISTANCE MEASUREMENT TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PINS AT ONE POINT IN TIME.
ON (B)(6) 2012, ADDITIONAL INFORMATION WAS RECEIVED WHEN IT WAS DISCOVERED THAT THE VNS PATIENT HAD A FULL REVISION SURGERY THAT DAY. SYSTEM DIAGNOSTICS PRIOR TO SURGERY CONFIRMED HIGH IMPEDANCE; OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7/EOS=NO. THE LEADS WERE REPLACED DUE TO HIGH IMPEDANCE AND THE GENERATOR WAS REPLACED DUE TO COMPATIBILITY WITH THE NEW LEADS. AFTER THE FULL REVISION SURGERY, THE SYSTEM DIAGNOSTICS TEST REVEALED RESULTS WITHIN NORMAL LIMITS OF LEAD IMPEDANCE=OK/IMPEDANCE VALUE=1202OHMS. THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6) 2012. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LEAD | LYJ | CYBERONICS, INC. | 300-20 | 813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |