PULSE GEN MODEL 105
Report
- Report Number
- 1644487-2013-02074
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- June 12, 2012
- Report Date
- May 17, 2017
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED BOTH THE GENERATOR AND LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
THE INFORMATION WAS INADVERTENTLY REPORTED ON AN ADDITIONAL MFR. REPORT (1644487-2014-00290). BRAND NAME, MODEL #, SERIAL #, LOT #, EXP. DATE, IMPLANT DATE AND MFG DATE: THE INFORMATION WAS INADVERTENTLY REPORTED INCORRECTLY ON THE INITIAL MFR. REPORT.
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
ON (B)(4) 2013 IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2013. PRE-OPERATIVE INTERROGATION SHOWED THE DEVICE AT SETTINGS OF OUTPUT=2MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=1.1MIN/MAGNET OUTPUT=2.75MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC/ERI=NO. MULTIPLE PRE-OPERATIVE SYSTEM DIAGNOSTICS WERE INCONSISTENT AND SHOWED IMPEDANCE VALUES RANGING FROM 5718 OHMS TO 7549 OHMS. THE GENERATOR WAS EXPLANTED AND THE SURGEON REPORTED HE COULD VISUALIZE THE LEAD PIN PAST THE CONNECTOR BLOCK AND THAT THE SET SCREW WAS TIGHT. A NEW GENERATOR WAS THEN CONNECTED TO THE EXISTING LEAD. PROPER PIN INSERTION WAS VERIFIED AND THE SET SCREW WAS TIGHTENED. SYSTEM DIAGNOSTICS RESULTED IN HIGH LEAD IMPEDANCE (>10,000OHMS). THE SURGEON THEN EXPLANTED THE LEAD. HE STATED THAT THERE WERE NO OBVIOUS ISSUES WITH THE VISIBLE PORTION OF THE LEAD EXTENDING FROM THE GENERATOR POCKET. HOWEVER, IN THE PROCESS OF REMOVING THE LEAD FROM THE NECK INCISION, HE REPORTED THAT ONE OF THE LEAD SEGMENTS PAST THE BIFURCATION WAS MILKY WHITE COLORED AND WAS NOT CONNECTED TO ANY HELICAL COIL. THE OTHER LEAD SEGMENT APPEARED NORMAL AND WAS CUT AS CLOSE TO THE HELICAL COIL AS POSSIBLE. HE WAS NOT SURE WHICH WIRE WAS WHICH DUE TO HEAVY SCARRING. ALL THREE HELICAL COILS FROM THE OLD LEAD WERE LEFT ON THE NERVE AND THE SURGEON REPORTED HE IMPLANTED THE NEW LEAD COILS DISTAL TO THE OLD HELICAL COILS. THE NEW GENERATOR WAS THEN CONNECTED TO THE NEW LEAD. PROPER PIN INSERTION WAS VERIFIED WITH THE SURGEON AND A SINGLE CLICK WAS HEARD WHEN TIGHTENING THE SET SCREW. TWO SYSTEM DIAGNOSTIC TESTS (ONE OUT-OF-POCKET AND ONE IN-POCKET) INDICATED OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=1164OHMS/ERI=NO AND OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=1124OHMS/ERI=NO RESPECTIVELY. THE SURGEON ORDERED THE NEW GENERATOR TO BE PROGRAMMED TO THE SAME SETTINGS AS THE OLD GENERATOR. FINAL INTERROGATION CONFIRMED SETTINGS OF OUTPUT=2MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=1.1MIN/MAGNET OUTPUT=2.75MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED FOR PRODUCT ANALYSIS ON (B)(4) 2013. PRODUCT ANALYSIS IS UNDERWAY AND HAS NOT YET BEEN COMPLETED.
ON (B)(6) 2013 INFORMATION WAS RECEIVED FROM THE REPORTER THAT THE PATIENT HAD A MEASUREMENT OF HIGH IMPEDANCE. THE PHYSICIAN OBSERVED A HIGH IMPEDANCE MESSAGE OF 6071 OHMS WHILE RUNNING SYSTEM DIAGNOSTICS FOR THE PATIENT DURING A (B)(6) 2013 VISIT. THE PHYSICIAN DID NOT DISABLE THE PATIENT¿S GENERATOR AFTER THE IMPEDANCE WARNING. X-RAYS WERE TAKEN OF THE PATIENT, BUT WILL NOT BE SENT TO THE MANUFACTURER DUE TO THE FORMAT IN WHICH THEY WERE RECORDED DOES NOT ALLOW FOR THE PHYSICIAN TO SEND THEM. THE PHYSICIAN STATED THAT THE PATIENT IS VERY ACTIVE AND THE PHYSICIAN DOES BELIEVE THAT MANIPULATION OR TRAUMA COULD HAVE POSSIBLY CONTRIBUTED TO THE HIGH IMPEDANCE. THE PHYSICIAN ALSO STATED THAT HE WOULD BE REFERRING THE PATIENT TO A NEUROSURGEON FOR EVALUATION. DEVICE MANUFACTURING RECORDS WERE REVIEWED FOR THE PATIENT¿S GENERATOR AND LEAD AND THE MANUFACTURING RECORDS CONFIRMED THAT THEY BOTH PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. A REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY WAS PERFORMED, SHOWING THAT PROGRAMMING HISTORY DATA IS AVAILABLE FROM (B)(6) 2011 TO (B)(6) 2013. HIGH IMPEDANCE WAS OBSERVED AS HAVING OCCURRED ON (B)(6) 2012 WITH A READING OF 6,202 OHMS DURING A SYSTEM DIAGNOSTICS TEST. HIGH IMPEDANCE WAS OBSERVED AS HAVING OCCURRED ON (B)(6) 2013 WITH A READING OF 6,071 OHMS DURING A SYSTEM DIAGNOSTICS TEST. BASED ON A ROUGH BATTERY LIFE ESTIMATION USING CALCULATION TABLES FOR THE MODEL OF GENERATOR IMPLANTED AND THE LAST KNOWN SETTINGS, THE GENERATOR IS NOT AT END OF SERVICE. FOLLOW-UP DETERMINED THAT THE PATIENT WAS SEEN FOR CONSULT BY A NEUROSURGEON ON (B)(6) 2013 AND THAT HE IS TENTATIVELY PLANNING A FULL VNS SYSTEM REVISION, BUT THAT SURGERY HAS YET TO BE SCHEDULED. ATTEMPTS FOR ADDITIONAL INFORMATION WILL REMAIN IN CONTINUATION.
IT WAS REPORTED THE PATIENT HAD AN ADDITIONAL SURGERY UNRELATED TO THE EVENT DISCUSSED WITHIN THIS MFR. REPORT. DURING THE SURGERY, THE SURGEON REMOVED THE REMAINING ELECTRODES WHICH WERE NOT PREVIOUSLY REMOVED DURING THE EXPLANT OF THE LEAD. THE EXPLANTED ELECTRODES HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.
REVIEW OF THE INVESTIGATION SHOWED THE LEAD DISCONTINUITY WAS LIKELY CAUSED BY A CHARGE IMBALANCE CAUSED BY THE M105 GENERATOR, ONCE A LEAD BECOMES COMPROMISED, CAUSING CORROSION WHICH CAN RESULT IN LEAD DISCONTINUITY. THIS INFORMATION WAS INITIALLY REPORTED CORRECTLY IN MFR. REPORT # 1644487-2014-00290. THE SECOND MFR. REPORT (1644487-2014-00290) WAS INADVERTENTLY CREATED BUT DID CORRECTLY REPORT THE INCIDENT.
THE LEAD ANALYSIS WAS COMPLETED ON 09/04/2013. NOTE THAT A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE FOLLOWING WAS FOUND DURING THE VISUAL ANALYSIS OF THE RETURNED 132MM PORTION: THE CONNECTOR PIN APPEARED TO BE PITTED. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED EVIDENCE OF SURFACE IRREGULARITIES, PITTING AND ELECTRO-ETCHING ON THE SURFACE OF THE CONNECTOR PIN. THE END OF THE (-) CONNECTOR PIN QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 78MM FROM THE END OF THE CONNECTOR BOOT. DISCOLORATION WAS OBSERVED ON THE (-) CONNECTOR PIN QUADFILAR COIL, IN SOME AREAS AND THE COIL APPEARED TO BE DISSOLVED IN OTHER AREAS, THROUGHOUT. 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. WITH THE EXCEPTION OF THE IDENTIFIED DISCONTINUITIES AND OBSERVED SURFACE IRREGULARITIES, PITTING AND ELECTRO-ETCHING OBSERVED ON THE CONNECTOR PIN SURFACE, THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ISSUES 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 PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED. SETSCREW MARKS WERE OBSERVED ON THE CONNECTOR PIN, PROVIDING EVIDENCE OF A PROPER MECHANICAL CONTACT BETWEEN CONDUCTIVE SURFACES OF BOTH THE GENERATOR AND CONNECTOR PIN. THE CONNECTOR PIN APPEARED TO BE PITTED. THE (+) CONNECTOR RING INTER-FACE BACKFILL APPEARED TO BE PARTIALLY DETACHED AND THE (+) CONNECTOR RING QUADFILAR COIL APPEARED TO BE KINKED. WHITE DEPOSITS WERE OBSERVED, IN SEVERAL AREAS. WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS WERE OBSERVED INSIDE THE OUTER AND (-) INNER SILICONE TUBING, IN SOME AREAS. AN ABRADED OPENING WAS OBSERVED ON THE OUTER SILICONE TUBING APPROXIMATELY 43MM-45MM FROM THE END OF THE CONNECTOR BOOT WITH THE INNER SILICONE TUBES AND QUADFILAR COILS PULLED AND LOOPED THRU. THE (-) CONNECTOR PIN QUADFILAR COIL APPEARED TO BE DISCOLORED, IN SOME AREAS. THE END OF THE (-) CONNECTOR PIN QUADFILAR COIL WAS OBSERVED AT APPROXIMATELY 78MM FROM THE END OF THE CONNECTOR BOOT. INCISIONS WERE MADE TO EXPOSE THE END OF THE COIL AND THE END APPEARED TO BE BROKEN. AN ABRADED OPENING WAS OBSERVED ON THE OUTER SILICONE TUBING APPROXIMATELY 82MM-86MM FROM THE END OF THE CONNECTOR BOOT. THE END OF THE OUTER SILICONE TUBING APPEARED TO BE ABRADED OPEN / CUT. THE FOLLOWING WAS FOUND ON THE RETURNED 47MM PORTION: THE END OF THE OUTER SILICONE TUBING APPEARED TO BE ABRADED OPEN / CUT. THE (-) CONNECTOR PIN QUADFILAR COIL APPEARED TO HAVE DISSOLVED. A SLICE MARK WAS OBSERVED ON THE OUTER SILICONE TUBING. THE MARK PENETRATED THE OUTER INSULATION. UNABLE TO DETERMINE IF THE INNER SILICONE TUBES WERE DAMAGED. A WHITE DEPOSIT WAS OBSERVED ON THE OUTER SILICONE TUBING. WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS WERE OBSERVED INSIDE THE OUTER SILICONE TUBING, THROUGHOUT. THE FOLLOWING WAS FOUND ON THE RETURNED 220MM PORTION: WHITE DEPOSITS WERE OBSERVED ON THE OUTER SILICONE TUBING. PORTIONS OF THE (-) CONNECTOR PIN QUADFILAR COIL APPEARED TO HAVE DISSOLVED. THE (-) CONNECTOR PIN QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 103MM, 134MM AND 185MM (WITH ABRADED OPENING ON INNER SILICONE TUBING) FROM THE END OF THE CUT / TORN OUTER SILICONE TUBING. DISCOLORATION WAS OBSERVED ON THE (-) CONNECTOR PIN QUADFILAR COIL. INCISIONS WERE MADE TO EXPOSE THE BROKEN COIL ENDS AND TO ALLOW FOR SEM PHOTOS. DURING THE CLEANING PROCESS A SMALL PORTION OF THE COIL BREAK FOUND AT 103MM BECAME DETACHED. A SLICE MARK WAS OBSERVED ON THE OUTER SILICONE TUBING. THE MARK PENETRATED THE OUTER INSULATION. UNABLE TO DETERMINE IF THE INNER SILICONE TUBES WERE DAMAGED. THE END OF THE (-) CONNECTOR PIN QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 220MM FROM THE END OF THE CUT / TORN OUTER SILICONE TUBING. NOTE THAT SINCE A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. THE GENERATOR ANALYSIS WAS COMPLETED ON 09/04/2013. VISUAL EXAMINATION PERFORMED REVEALED SCRATCHES ON THE GENERATOR CAN MOST LIKELY ASSOCIATED WITH THE EXPLANT PROCEDURE. THE SEPTUM WAS NOT CORED, BUT BODY FLUID REMNANTS WERE NOTED ON THE CONNECTOR BLOCK. BODY FLUID REMNANTS WERE ALSO NOTED ON THE CANTED SPRING. NO OTHER SURFACE ABNORMALITIES WERE NOTED ON THIS DEVICE. THE GENERATOR IS OPERATING WITHIN SPECIFICATION. RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE WAS OPERATING PROPERLY. OTHER THAN THE OBSERVED CONDITION OF BODY FLUIDS REMNANTS ON THE CONNECTOR BLOCK AND CANTED SPRING, THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320622 | PULSE GEN MODEL 105 | GENERATOR | LYJ | CYBERONICS, INC. | 105 | 2899 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |