BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2120198 · Received June 6, 2011

    Report

    Report Number
    6000031-2011-04036
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    March 15, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MILACA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THERE WAS A SUSPECTED ALLERGIC REACTION AT THE IMPLANT SITE. AN ALLERGY TEST WAS TO BE PERFORMED. AN ALLERGY WAS SUSPECTED TO BE LOCATED NOT AT THE INS POCKET SITE BUT ALONG THE EXTENSION. SYMPTOMS IN THE SKIN INCLUDED RED AND PAINFUL AREA AND WHEN THE DEVICE WAS EXPLANTED EXCUDATE WAS PRESENT. THE SYSTEM WAS REMOVED AND THE PT RETURNED TO USING ORAL MEDICATION FOR PAIN CONTROL. NO CONFIRMED ALLERGY TEST WAS AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MILACA 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU222504V| EXTENSION: MODEL 7489, LOT# NHU222505V| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# 0203877849| EXPLANTED:| LEAD: MODEL 3998, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: