BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENERATOR

    MDR report key: 825019 · Received July 13, 2006

    Report

    Report Number
    1644487-2006-00255
    Event Type
    Other
    Date Received
    July 13, 2006
    Date of Event
    March 23, 2006
    Report Date
    May 19, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    VNS THERAPY SYSTEM LABELING LISTS INFECTION AS A POTENTIAL ADVERSE EVENT POSSIBILY ASSOCIATED WITH SURGERY.

    Additional Manufacturer Narrative · 1

    CORRECT DATA: FOLLOW-UP REPORT #1 SHOULD NOT HAVE BEEN SUBMITTED. THE INFORMATION ABOUT THE EXPLANTED OF THE PATIENT¿ GENERATOR WAS INADVERTENTLY REPORTED IN FOLLOW-UP REPORT #1 AS THE EXPLANT AND IRRELEVANT TO THE INFECTION. SINCE THE EXPLANT WAS REPORTED THE MANUFACTURER CONTINUED TO REPORT RELEVANT INFORMATION REGARDING THE EXPLANT.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION, CORRECTED DATA: AS THE DEVICE EXPLANT WAS PERFORMED ABOUT 6 YEARS AFTER THE INFECTION WAS REPORTED, IT IS LIKELY THE EXPLANT WAS NOT RELATED TO THE INFECTION. THEREFORE, THE INFORMATION IS SUPPLEMENTAL MDRS 1, 2, AND 3, ABOUT THE EXPLANT AND PA RESULTS ARE NOT RELEVANT TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THIS GENERATOR WAS EXPLANTED AND REPLACED. THE DEVICE WAS REPORTEDLY EXPLANTED ON (B)(6) 2013 DUE TO BATTERY REPLACEMENT. THE DEVICE HAS NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    THE GENERATOR WAS RECEIVED ON (B)(4) 2013 FOR ANALYSIS. A RETURNED PRODUCT FORM INDICATED THAT THE REASON FOR REVISION WAS PROPHYLACTIC.

    Description of Event or Problem · 1

    AS THE GENERATOR EXPLANT OCCURRED ABOUT 6 YEARS AFTER THE INFECTION WAS REPORTED, THE EXPLANT WAS LIKELY NOT RELATED TO THE INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. THE MANUFACTURING RECORDS SHOW THAT THE PULSE GENERATOR PASSED ALL SPECIFICATIONS BEFORE IT WAS RELEASED. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PT DEVELOPED AN INFECTION AT THE CHEST INCISION SITE POST IMPLANT. THE CHEST POCKET WAS IRRIGATED AND THE INFECTION WAS TREATED WITH ANTIBIOTICS. REVIEW OF MANUFACTURTING RECORDS FOR THE PULSE GENERATOR CONFIRMED STERILIZATION OF DEVICE. AVAILABLE INFO SUGGESTS THAT THE EVENT WAS RELATED TO THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR PULSE GENERATOR (INDICATION UNKNOWN) LYJ CYBERONICS, INC. 102 12991

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other LEAD MODEL 302