BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 2993081 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00628
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 12, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTER INDICATED INTERVENTIONS FOR THE INFECTION INCLUDED WOUND EXPLORATION/DEBRIDEMENT AND INTRAVENOUS ANTIBIOTIC THERAPY VIA PICC LINE FOR 3 WEEKS. WOUND CULTURES WERE NEGATIVE, BUT NO MORE INFORMATION WAS PROVIDED. THE PATIENT'S INFECTION HAS COMPLETELY RESOLVED PER THE REPORTER.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT DEVELOPED AN INFECTION AT THE VNS GENERATOR SITE FOLLOWING VNS GENERATOR REPLACEMENT SURGERY THAT OCCURRED ON (B)(6) 2013. THE INFECTION IS FELT TO BE DUE TO THE PATIENT PICKING AT THE WOUND SITE. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98299 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 202194

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other