BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2960260 · Received February 8, 2013

    Report

    Report Number
    3006556115-2013-00043
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S IMPLANT SITE BECAME INFECTED WITH PRESENCE OF PUS. THE PT WAS REPORTEDLY PRESCRIBED ANTIBIOTICS (TYPE AND DURATION UNK), HOWEVER THIS DID NOT RESOLVE THE ISSUE. THE PT'S DEVICE WAS EXPLANTED. RE-IMPLANTATION WILL BE RECONSIDERED AT A LATER DATE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE MORE INFO IS REC'D A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53515 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention