BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACURIS S

    MDR report key: 3555159 · Received November 14, 2013

    Report

    Report Number
    3005019184-2013-00001
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    May 2, 2006
    Report Date
    November 14, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS; HOWEVER, IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. INVESTIGATION AND CONCLUSION: TESTING ON THE RETURNED HEARING AID SHOWED COMPLIANCE TO SPECIFICATIONS. THE MAGNETIC FIELD OF THE RETURNED HEARING AID WAS COMPARED TO TWO OTHER ACURIS S HEARING AIDS FROM THE INVENTORY WITHOUT SIGNIFICANT DIFFERENCE. DUE TO THE EXTREMELY LOW ELECTROMAGNETIC FIELD OF THE ACURIS S BTE, A RELATION TO THE INCIDENT CAN BE EXCLUDED. NO SIMILAR EVENTS HAVE COME TO OUR ATTENTION. THE PRACTITIONER REPORTING THE INCIDENT TO US HAS BEEN NOTIFIED IN WRITING.

    Description of Event or Problem · 1

    WHILE WEARING ACURIS S BTE HEARING AID AND WORKING ON A PARTICULAR COMPUTER MONITOR, THE PATIENT EXPERIENCED A SHOCK, VERTIGO, SICKNESS AND VOMITING. THE PATIENT VISITED A DOCTOR AND THE DOCTOR DIAGNOSED THAT THE HEARING AID MAY BE RESPONSIBLE FOR THESE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591421 ACURIS S BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention