BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 2915836 · Received January 15, 2013

    Report

    Report Number
    1644487-2013-00157
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE EXPLANTED GENERATOR FOUND THAT THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.932 VOLTS AS MEASURED DURING COMPLETION OF TEST PARAMETER (B)(4) (MEASURED DIAGVBAT) OF THE FINAL ELECTRICAL TEST, SHOWS A-NON IFI CONDITION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 6.480% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. ALTHOUGH THE PRODUCT ANALYSIS RESULTS INDICATE THE DEVICE WAS NOT AT END OF SERVICE, IT WAS CONFIRMED THAT THE EOS FLAG WAS VISUALIZED WHILE PERFORMING DIAGNOSTICS. ADDITIONALLY, IT WAS STATED THAT THE HIGH IMPEDANCE WAS OBSERVED FOR OVER SIX MONTHS AND THAT THERE WERE NO BELIEVED SOFTWARE ISSUES WITH THE PROGRAMMING SYSTEM. PRODUCT ANALYSIS WAS PERFORMED ON THE RETURNED PORTIONS OF THE EXPLANTED LEAD. A BREAK WAS IDENTIFIED IN THE POSITIVE COIL. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW APPEARANCE SUGGESTING THAT A STRESS-INDUCED FRACTURE (MOST LIKELY DUE TO ROTATIONAL FORCES) HAS OCCURRED ON THE COIL. SECONDARY FRACTURES NOTED IN THE POSITIVE COIL STRANDS APPEAR TO INDICATE THE STRESS-RELATED PRIMARY FRACTURES WERE MOST LIKELY CREATED DURING THE EXPLANT PROCEDURE. OTHER THAN THE IDENTIFIED LEAD BREAK NO OBVIOUS REASON FOR THE REPORTED ¿HIGH IMPEDANCE¿ ALLEGATION WAS IDENTIFIED WITHIN THE RETURNED LEAD. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEAR TO BE ORGANIC MATTER AT APPROXIMATELY 0.3CM (POSITIVE COIL) AND 1.8CM (NEGATIVE) PAST ANCHOR TETHER. THE ORGANIC MATTER WAS REMOVED TO PERFORM PROPER INSPECTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013.THE PIN INSERTION WAS DOUBLE-CHECKED A FEW TIMES AND THE HIGH IMPEDANCE PERSISTS. A DEVICE WAS REPLACED BUT UNKNOWN IF THE LEAD WAS REPLACED.GOOD FAITH ATTEMPTS ARE UNDERWAY TO DETERMINE WHAT WAS DONE DURING THE SURGERY AND WHAT EXPLAINED PRODUCT IS BEING RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD BEEN PROGRAMMED ONLY ONCE ((B)(6) 2012) PRIOR TO THIS INCIDENT AND THE PARAMETERS WERE THE FOLLOWING: OUTPUT CURRENT 0.25, SIGNAL FREQUENCY 30, PULSE WIDTH 500; SIGNAL ON TIME 30, SIGNAL OFF TIME , 5, MAG CURRENT 0.50; MAG ON TIME 60, MAG PULSE WIDTH 500. NO X-RAYS ARE AVAILABLE FOR REVIEW. NO REPORT OF ANY PATIENT TRAUMA OR MANIPULATION. NO INTERVENTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013 DUE TO BATTERY DEPLETION AND HIGH IMPEDANCE. THE EXPLANTED DEVICES WERE RETURNED ON (B)(4) 2013 AND ARE CURRENTLY UNDERGOING ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT A HIGH IMPEDANCE WARNING MESSAGE WAS RECEIVED INDICATING THAT AN IMPEDANCE VALUE GREATER THAN OR EQUAL TO 10,000OHMS WAS DETECTED. THE X-RAYS WERE STATED TO HAVE BEEN REVIEWED BY THE PHYSICIAN AND NO ABNORMALITIES WERE DETECTED. THE PATIENT AND PRODUCT INFORMATION WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23122 LEAD MODEL 304 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20 3083

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR