PULSE GEN MODEL 102
Report
- Report Number
- 1644487-2011-01536
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- April 1, 2011
- Report Date
- June 8, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4), 2012 WHEN THE EXPLANTED PRODUCTS WERE RECEIVED BY THE MANUFACTURER FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED. ALTHOUGH THE RETURNED PRODUCT FORM FILLED OUT BY THE HOSPITAL STATES THAT THE REASON FOR SURGERY WAS A LEAD DISCONTINUITY, THE NEUROLOGIST STATED THAT THE REASON FOR SURGERY WAS ACTUALLY BECAUSE THE PATIENT WAS EXPERIENCING A WORSENING OF SEIZURES AND NOT A LEAD DISCONTINUITY. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 3.21 YEARS UNTIL THE ELECTIVE REPLACEMENT INDICATOR SHOWED YES.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. PRODUCT ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(4), 2012. 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 TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS. SETSCREW MARKS WERE SEEN ON THE CONNECTOR PIN TOWARDS THE END TIP OF THE PIN, PROVIDING EVIDENCE THAT CONTACT BETWEEN THE SETSCREW AND THE LEAD PIN EXISTED, HOWEVER THE LOCATION OF THE SETSCREW MARKS SUGGEST THAT THE CONNECTOR PIN WAS NOT INSERTED COMPLETELY AT ONE POINT IN TIME. THE EXACT POINT IN TIME OF WHEN THIS OCCURRED IS UNKNOWN. HOWEVER, BASED IN THE LOCATION OF THE SETSCREW MARKS ON THE CONNECTOR PIN AND SCRATCHES FROM THE CANTED SPRING OBSERVED ON THE CONNECTOR RING, IT IS BELIEVED THAT PROPER CONTACT BETWEEN THE PULSE GENERATOR "+" AND "-" TERMINALS AND THE LEAD CONNECTOR RESPECTIVE CONTACT POINTS EXISTED AT LEAST ONCE. THE LEAD CONNECTOR HAS PARTIAL DETACHMENT AT THE RING/BACKFILL INTERFACE. THE REASON FOR THIS CONDITION IS UNKNOWN. NO ADVERSE EFFECT WAS IDENTIFIED ON THE DEVICE PERFORMANCE AS A RESULT OF THIS CONDITION. THE OUTER SILICONE TUBING WAS ABRADED OPEN AT APPROXIMATELY 34CM FROM BOOT. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS TO BE DRY BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENINGS AND THE ENDS OF THE RETURNED LEAD PORTIONS. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS.
IT WAS REPORTED THAT THE PT WAS TO HAVE REVISION SURGERY FOR AN UNK REASON. FURTHER INFO REVEALS THAT THE PT WAS EXPERIENCING AN INCREASE IN SEIZURES IN (B)(6) 2011. SYSTEM AND NORMAL MODE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE PT UNDERWENT REVISION SURGERY DUE TO CLINICAL SYMPTOMS ON (B)(6) 2011. ATTEMPTS FOR FURTHER INFO AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 016740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |