LEAD MODEL 302
Report
- Report Number
- 1644487-2013-01130
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 28, 2013
- Report Date
- April 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
- MN, US
- Reporter Occupation
- NURSE
Narratives
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
ANALYSIS OF PROGRAMMING HISTORY. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.
ON (B)(4) 2013 IT WAS REPORTED THAT THE VNS PATIENT WAS SEEN ON (B)(6) 2013 AND LOW IMPEDANCE WAS OBSERVED. IT WAS UNKNOWN SPECIFICALLY WHAT DIAGNOSTIC TEST WAS RUN, OR WHAT THE FULL RESULTS WERE OF THE DIAGNOSTICS TESTS. THE REPORTER DID SAY THAT THE PATIENT RECENTLY STARTED COMPLAINING OF DISCOMFORT WITH STIMULATION, AND TWITCHING OF THE MUSCLES IN HER NECK WITH STIMULATION. THE REPORTER STATED THAT ACCORDING TO HER NOTES, THE PATIENT WAS SEEN ON (B)(6) 2012 AND THE PARAMETER SETTINGS WERE INCREASED AT THAT TIME, AND THEN ABOUT A MONTH OR TWO AFTER, THE PATIENT REPORTED THIS DISCOMFORT AND NECK SPASMS. THE PATIENT WAS THEN SEEN ON (B)(6) 2013, BUT THEY DID NOT CHANGE ANY SETTINGS BECAUSE THE PATIENT WAS TOLERATING THESE ISSUES, EVEN THOUGH IT WAS STILL BUGGING HER. NO DIAGNOSTIC TESTING WAS PERFORMED AT THAT TIME. THE REPORTER STATED THAT AT THE MOST RECENT APPOINTMENT ON (B)(6) 2013, THE PATIENT ASKED FOR THE SETTINGS TO BE LOWERED BECAUSE OF THE DISCOMFORT AND NECK SPASMS, SO THE PHYSICIAN LOWERED THE OUTPUT CURRENT FROM 2.25MA TO 1.75MA. THE PHYSICIAN THEN RAN DIAGNOSTICS WHICH IS WHEN LOW IMPEDANCE WAS OBSERVED. THE MANUFACTURING RECORDS FOR THE LEAD WERE REVIEWED AND THE DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 3.02 YEARS REMAINING UNTIL ERI=YES. THE PHYSICIAN LATER REPORTED THAT X-RAYS WERE PERFORMED BUT THEY HAVE NOT BEEN SENT TO THE MANUFACTURER TO DATE. THE PATIENT REPORTED THAT THE MUSCLE TWITCHING BEGAN AFTER THE PATIENT'S MAMMOGRAM IN (B)(6) 2013. THE PHYSICIAN NOTED THAT THE OUTPUT WAS DISABLED DUE TO THE LOW IMPEDANCE. NO FURTHER INFORMATION WAS PROVIDED BY THE PHYSICIAN.
AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO LEAD DISCONTINUITY. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO THE MANUFACTURER TO DATE.
THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.
ON (B)(4) 2014 PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS; THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. PRODUCT ANALYSIS ON THE LEAD WAS COMPLETED ON (B)(4) 2014. ABRADED OPENINGS WERE NOTED ON THE OUTER AND THE INNER SILICONE TUBING. A SINGLE BROKEN STRAND WAS NOTED ON THE POSITIVE COIL. SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.
ON (B)(6) 2013 IT WAS REPORTED THAT ABOUT A MONTH AGO, LOW IMPEDANCE WAS OBSERVED. THE DEVICE WAS TURNED OFF ON (B)(6) 2013 DUE TO THE LOW IMPEDANCE. X-RAYS HAD BEEN PERFORMED AND THE RADIOLOGIST WAS NOT ABLE TO SEE ANYTHING OF SIGNIFICANCE. THE PATIENT EXPLAINED THAT SHE HAD A MAMMOGRAM PERFORMED WITHIN A WEEK OR TWO OF THE TIME THAT THE DEVICE STOPPED WORKING AND WAS VERY SPECIFIC WITH THE TECHNICIAN ABOUT HER IMPLANT. THE PATIENT BELIEVES THAT THE MAMMOGRAM MAY HAVE BEEN RELATED TO THIS LOW IMPEDANCE CONDITION. SHE EXPLAINED THAT AFTER THE MAMMOGRAM, SHE BEGAN TO EXPERIENCE PAINFUL STIMULATION AND FELT THAT THE MUSCLES IN HER NECK WERE ¿RETRACTING.¿ SHE ALSO MENTIONED THAT SHE WAS FEELING PAIN AT HER BREAST SITE LIKE THE AREA WAS BEING ¿PINCHED.¿ A COPY OF THE PATIENT¿S X-RAYS WERE RECEIVED FOR REVIEW. WHETHER THE LEAD PIN WAS FULLY INSERTED INTO THE HEADER OF THE GENERATOR COULD NOT BE ASSESSED BASED ON THE ANGLE OF THE GENERATOR IN THE IMAGES. THERE WAS A PORTION OF THE LEAD LOCATED BEHIND THE GENERATOR THAT COULD NOT BE ASSESSED. THERE DID NOT APPEAR TO BE ANY LEAD DISCONTINUITIES IN THE PORTION OF THE LEAD THAT COULD BE VISUALIZED. THERE APPEARED TO BE A PROPER STRAIN RELIEF BEND BUT THERE DID NOT APPEAR TO BE A STRAIN RELIEF LOOP. BASED ON THE X-RAY IMAGES PROVIDED, AN EXACT CAUSE FOR THE REPORTED EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LEAD PIN COULD NOT BE CONFIRMED TO BE FULLY INSERTED AND A PORTION OF THE LEAD COULD NOT BE VISUALIZED IN THE CHEST DUE TO IT BEING BEHIND THE GENERATOR. ALSO, THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD CANNOT BE RULED OUT. THE PATIENT STATED THAT SHE HAD A MAMMOGRAM ON (B)(6) 2013 AND THAT ON (B)(6) 2013 THE VNS READ LOW IMPEDANCE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.
ON (B)(6) 2013, THE PATIENT REPORTED THAT WHEN SHE HAD A MAMMOGRAM , THEY BROKE THE VNS WIRE AND AFTERWARDS THE DEVICE READ LOW IMPEDANCE. SURGERY, ALTHOUGH LIKELY, STILL HAS NOT YET OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173857 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS, INC. | 302-20 | 1766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |