BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3213381 · Received July 3, 2013

    Report

    Report Number
    3006556115-2013-00301
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    February 1, 2013
    Report Date
    June 15, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT COMPLAINED OF PAIN AFTER HITTING THE HEAD AT THE IMPLANT SITE IN (B)(6) OF 2013. THE PT WAS PLACED ON ANTI-INFLAMMATORY (TYPE UNK) AND ANTIBIOTIC (ZINNAT). IN (B)(6) OF 2013, THE PT'S INTERNAL DEVICE HAD REPORTEDLY MIGRATED AND BEGAN TO EXTRUDE THROUGH THE SKIN. ON (B)(6) 2013, THE PT WAS PLACED ON ANTI-INFLAMMATORY MEDICATION (TYPE UNK) AND CEFADROXIL FOR 10 DAYS. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS IMPLANTED IN THE CONTRALATERAL EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303623 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Required Intervention