BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2100294 · Received May 16, 2011

    Report

    Report Number
    1644487-2011-01076
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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

    ON (B)(6) 2011, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED BY CASE MANAGEMENT. REVIEW OF THE CLINIC NOTES REVEALED THAT THE PATIENT WAS BEING REFERRED FOR PROPHYLACTIC BATTERY REPLACEMENT. A BLC PERFORMED ON (B)(6) 2011, HAD SHOWED 0.6 YEARS UNTIL ERI = YES. ADDITIONAL CLINIC NOTES WERE RECEIVED BY THE PHYSICIAN REPORT THAT ON (B)(6) 2011, THE PATIENT'S FAMILY HAS NOTICED AN INCREASE IN SEIZURES AND THEY THINK THE BATTERY MIGHT BE LOW. THE PATIENT WENT FOR BATTERY REPLACEMENT SURGERY ON (B)(6) 2011. DURING SURGERY AFTER THE NEW GENERATOR WAS ATTACHED TO THE PATIENT'S IMPLANTED LEADS, SYSTEM DIAGNOSTICS REVEALED HIGH IMPEDANCE; OUTPUT = LIMIT/ LEAD IMPEDANCE = HIGH/ DCDC = 7/ EOS = NO. THE SURGEON UNATTACHED THE GENERATOR FROM THE LEADS AND THEN INSERTED THE TEST RESISTOR AND RAN DIAGNOSTICS AGAIN WHICH RESULTED IN LEAD IMPEDANCE = OK/ DCDC = 2/ EOS = NO. THE SURGEON THEN RE-ATTACHED THE GENERATOR TO THE LEADS AND THE SYSTEM DIAGNOSTICS AGAIN RESULTED IN HIGH LEAD IMPEDANCE. THE SURGEON DID NOT WANT TO REPLACE THE PATIENT'S LEADS AT THAT TIME SO THE PATIENT WAS PROGRAMMED TO 0MA. A SYSTEM DIAGNOSTIC TEST HAD NOT BEEN PERFORMED RIGHT BEFORE SURGERY. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2011 THAT HAS NOT YET BEEN COMPLETED. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 11863

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention