BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR BAHA ATTRACT SYSTEM

    MDR report key: 5874796 · Received August 14, 2016

    Report

    Report Number
    6000034-2016-01542
    Event Type
    Injury
    Date Received
    August 14, 2016
    Report Date
    July 22, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 15, 2016, BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR (B)(4). (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THE CORRECT 510K NUMBER IS K131240, NOT K121317 AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME AND PRODUCT CODE IS LXB, NOT MAH AS PREVIOUSLY REPORTED. THE CORRECT BRAND NAME IS COCHLEAR BAHA ATTRACT SYSTEM, NOT FLANGE FIXTURE AND ABUTMENT AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A NERVE BLOCK PROCEDURE ON (B)(6) 2016 UNDER LOCAL ANESTHETIC TO ADMINISTER A STEROID INJECTION.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN WITH AND WITHOUT DEVICE USE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE, DATE AND DURATION NOT REPORTED) HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS PLANNED; HOWEVER, IT IS UNKNOWN WHETHER THIS HAS YET TO TAKE PLACE, AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526778 COCHLEAR BAHA ATTRACT SYSTEM LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 90863

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention