BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2011597 · Received March 1, 2011

    Report

    Report Number
    3006556115-2011-00091
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    August 20, 2007
    Report Date
    February 8, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS EVENT AS CLOSED. THE PATIENT DEVICE REMAINS IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN EDEMA AT THE IMPLANT SITE. THE DOCTOR DRAINED THE FLUID FROM THE EDEMA. AFTER THE PROCEDURE, THE PT WAS CLEARED FOR EXTERNAL EQUIPMENT USE. THE ISSUE HAS BEEN RESOLVED AND THE EDEMA HAS NOT RE-OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention