LEAD MODEL 302
Report
- Report Number
- 1644487-2013-00072
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- December 26, 2012
- Report Date
- December 26, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
NEW INFORMATION RECEIVED CORRECTS THE DATE OF EXPLANT.
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE IS OCCURRED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
ON (B)(6) 2012, IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN IN REGARDS TO THIS PATIENT'S DEVICE. AFTER THE FIRST INTERROGATION, THE OUTPUT CURRENT WAS REDUCED BY 0.25 MA, AND THE PULSEWIDTH WAS REDUCED FROM 500 USEC TO 250 USEC. ANOTHER DIAGNOSTIC TEST WAS PERFORMED WITH HIGH IMPEDANCE RESULTS. THE PATIENT WAS LAST SEEN ON (B)(6) 2011. PROGRAMMING HISTORY WAS ALSO PROVIDED. PER THE PATIENT'S MOTHER, THE PATIENT MANIPULATED THE DEVICE OFTEN. THE GENERATOR WAS DESCRIBED AS VERY SUPERFICIAL AND PALPABLE. FOLLOW-UP SHOWED THAT PATIENT MANIPULATION WAS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE EVENTS. THE DEVICE WAS NOT DISABLED. IT WAS UNKNOWN WHEN THE DEVICE PROTRUSION BEGAN, BUT THE PATIENT HAD LOST WEIGHT WITHIN THE LAST YEAR, WHICH MAY HAVE CONTRIBUTED TO THE PROTRUSION. THE PHYSICIAN DID NOT ALLEGE THAT THE BODY WAS REJECTING THE DEVICE. NO INTERVENTIONS WERE TAKEN FOR THE PROTRUSION EVENT. THE WEIGHT LOSS WAS THE CAUSE OF THE EXCESS OF MANIPULATION OF THE GENERATOR BY THE PATIENT. A/P AND LATERAL VIEWS OF THE NECK AND A/P VIEW OF THE CHEST WERE REVIEWED. THE REPORTED EVENTS ARE HIGH LEAD IMPEDANCE AND GENERATOR PROTRUSION. THE GENERATOR WAS VISUALIZED IN THE PATIENT'S LEFT CHEST. THE LEAD APPEARED TO BE INTACT AT THE LEAD PIN AND THE LEAD PIN WAS SEEN PAST THE CONNECTOR BLOCKS INDICATING COMPLETE LEAD PIN INSERTION. THE INTEGRITY OF THE FILTER FEEDTHRU WIRES COULD NOT BE ASSESSED DUE TO THE ANGLE OF THE X-RAYS PROVIDED. FOR THE SAME REASON, IT COULD NOT BE CONFIRMED WHETHER OR NOT THERE WAS ANY LEAD BEHIND THE GENERATOR. THE LEAD WAS SEEN IN THE LEFT SIDE OF THE PATIENT'S NECK. NO SHARP ANGLES WERE SEEN IN THE PORTIONS OF THE LEAD THAT COULD BE VISUALIZED; HOWEVER, THERE WAS A PORTION OF THE LEAD BY THE GENERATOR THAT COULD NOT BE SEEN DUE TO THE ANGLE OF THE X-RAY IMAGES PROVIDED. A LEAD DISCONTINUITY WAS SEEN IN THE LEAD BIFURCATION. FOLLOW-UP SHOWED THAT THE WEIGHT LOSS WAS NOT BELIEVED TO BE RELATED TO VNS. THE PATIENT DID NOT OFTEN GO TO APPOINTMENTS, SO THE WEIGHT LOSS WAS ONLY NOTICED AT A RECENT APPOINTMENT. THE PATIENT'S MOTHER INDICATED THAT THE WEIGHT LOSS BEGAN ONE YEAR AGO. NO INTERVENTIONS FOR THIS WERE TAKEN. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN BELIEVED THAT THE GENERATOR BATTERY DEPLETED TOO QUICKLY. A BATTERY LIFE CALCULATION (RESULTS PREVIOUSLY REPORTED) AND REVIEW OF PROGRAMMING HISTORY SHOWED NORMAL BATTERY DEPLETION.
ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2014. THE MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(4) 2014. NOTE THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS OF THE RETURNED 157MM PORTION QUADFILAR COIL 1 APPEARED TO BE BROKEN APPROXIMATELY 5MM FROM THE ELECTRODE BIFURCATION. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. DURING THE VISUAL ANALYSIS OF THE RETURNED 157MM PORTION QUADFILAR COIL 2 APPEARED TO BE BROKEN APPROXIMATELY 15MM FROM THE ELECTRODE BIFURCATION. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA ON TWO OF THE BROKEN COIL STRANDS AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (FATIGUE APPEARANCE) WITH MECHANICAL DAMAGE AND NO PITTING. THE AREA ON THE REMAINING BROKEN COIL STRANDS WAS IDENTIFIED AS BEING MECHANICALLY DAMAGED WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE AND NO PITTING. 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 ABRADED OPENINGS FOUND ON THE OUTER AND INNER SILICONE TUBES MOST LIKELY PROVIDED THE LEAKAGE PATH FOR THE DRIED REMNANTS OF WHAT APPEARED TO HAVE ONCE BEEN BODY FLUIDS FOUND INSIDE THE OUTER AND INNER SILICONE TUBES. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED IN VARIOUS LOCATIONS. EDS (ENERGY DISPERSION SPECTROSCOPY ¿ PROVIDES CHEMICAL OR ELEMENT IDENTITY/COMPOSITION ANALYSIS) WAS PERFORMED AND IDENTIFIED THE DEPOSIT AS CONTAINING SILICON, PHOSPHORUS, SODIUM, MAGNESIUM, ALUMINUM AND CALCIUM. 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 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.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR STATING THAT THE VNS PATIENT WAS BEING SCHEDULED FOR SURGERY TO HAVE THE GENERATOR AND LEAD EXPLANTED, AND THE GENERATOR HAD REACHED END OF SERVICE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WILL NOT BE RE-IMPLANTED WITH A NEW DEVICE FOR REASONS UNKNOWN. THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY. ATTEMPTS TO OBTAIN THE DATE THE DEVICES WERE EXPLANTED ARE UNDERWAY.
IT WAS REPORTED THAT THE GENERATOR WAS EXPLANTED ON (B)(6) 2014.
A/P AND LATERAL VIEWS OF THE CHEST AND NECK, DATED (B)(6) 2013, WERE RECEIVED AND REVIEWED. THE GENERATOR WAS VISUALIZED IN NORMAL ORIENTATION IN THE PATIENT¿S LEFT CHEST AREA. THE LEAD APPEARED TO BE INTACT AT THE LEAD PIN AND THE FILTER FEEDTHRU WIRES APPEAR INTACT. THE LEAD PIN COULD NOT BE SEEN PAST THE SECOND CONNECTOR BLOCK IN THE IMAGE, THEREFORE IT COULD NOT BE ASSESSED IF THE LEAD PIN WAS FULLY INSERTED. A PORTION OF THE LEAD APPEARED BEHIND THE GENERATOR AND COULD NOT BE ASSESSED. THE LEAD WAS SEEN IN THE LEFT SIDE OF THE PATIENT¿S NECK. A STRAIN RELIEF LOOP WAS OBSERVED; HOWEVER, A STRAIN RELIEF BEND DID NOT APPEAR TO BE PRESENT. NO SHARP ANGLES WERE OBSERVED IN THE PORTIONS OF THE LEAD THAT COULD BE VISUALIZED; HOWEVER, A POSSIBLE LEAD DISCONTINUITY WAS SEEN IN THE LEAD BODY. BASED ON THE X-RAY IMAGES, IT IS POSSIBLE THAT THE HIGH IMPEDANCE IS DUE TO A LEAD DISCONTINUITY. ADDITIONALLY, MICRO-FRACTURES IN THE LEAD CANNOT BE RULED OUT. NO FURTHER INTERVENTIONS HAVE BEEN TAKEN SINCE THE LAST REPORT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31125 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS, INC. | 302-20 | 200635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |