BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3882214 · Received June 18, 2014

    Report

    Report Number
    1644487-2014-01532
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SWELLING AND ERYTHEMA IN THE AREA OF THE GENERATOR. IT APPEARS TO BE DIRECTLY RELATED TO THE DEVICE AND THE ERYTHEMA EXTENDS BELOW THE SWELLING TOWARDS THE PATIENT'S LEFT NIPPLE AND LATERALLY TOWARDS THE AXILLA. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND EXPLORATORY SURGERY WAS CONSIDERED. FURTHER FOLLOW-UP REVEALED THAT EXPLANT SURGERY WAS PLANNED, BUT IT WAS REPORTED THAT IF THE INFECTION RESOLVES BY THE NEXT VISIT THE DEVICE WILL NOT BE REMOVED. IT WAS LATER REPORTED THAT THE SITE WAS MUCH LESS SWOLLEN AND INFLAMED AND THAT THE PATIENT HAS RESPONDED WELL TO THE ANTIBIOTICS. THE EXPLANT SURGERY WAS CANCELLED AND THE PATIENT WAS GIVEN AN ADDITIONAL WEEK OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358671 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 201717

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention