BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 3883387 · Received June 19, 2014

    Report

    Report Number
    1644487-2014-01534
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    March 9, 2014
    Report Date
    May 22, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014, THE SURGEON CUT THE VNS PATIENT¿S LEAD. THE SURGEON COULD NOT FIX THE LEAD OR IMPLANT A NEW LEAD. THE PATIENT¿S DEVICE WAS EXPLANTED EXCEPT FOR THE ELECTRODE AND CUT LEAD. AFTER SURGERY, THE PATIENT WAS ONLY ON MEDICATION AND HIS CONDITION DETERIORATED. THE PATIENT WAS RE-IMPLANTED WITH A NEW GENERATOR AND LEAD ON (B)(6) 2014. THE PATIENT¿S EXISTING LEAD WAS EXPLANTED DURING THE REPLACEMENT SURGERY BUT IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360732 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 10644

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention