BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPOCKET

    MDR report key: 3561571 · Received November 14, 2013

    Report

    Report Number
    3005019184-2013-00032
    Event Type
    Other
    Date Received
    November 14, 2013
    Date of Event
    August 26, 2005
    Report Date
    November 14, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE MAGNETIC FIELD RADIATION TEST OF THE RETURNED PRODUCT WAS WITHIN THE SPECIFIED TOLERANCE FOR EPOCKET. IT WAS CONCLUDED THAT THE ALLEGED PASSING OUT OF THE USER IS NOT RELATED TO THE APPLICATION OF EPOCKET. THE USAGE OF EPOCKET WITH A PACEMAKER WAS EVALUATED AS UNCRITICAL BY THE SIEMENS SAFETY BOARD. AS A PREVENTIVE MEASURE IT WAS DECIDED TO ADD A WARNING REGARDING THE OPERATION OF EPOCKET IN COMBINATION WITH IMPLANTABLE DEVICES TO THE USER MANUAL IN ORDER TO PROVIDE FOR UNFORESEEABLE FUTURE DEVELOPMENTS IN THE IMPLANTABLE DEVICE TECHNOLOGY. (B)(4).

    Description of Event or Problem · 1

    PT ALLEGES SHE WAS WEARING AN ACURIS HEARING AID AND USED HER EPOCKET REMOTE CONTROL UNIT TO CHANGE SOME SETTINGS WHILE SHE WAS DRIVING DOWN THE ROAD IN HER AUTOMOBILE. PT ALLEGES WHILE OPERATING THE EPOCKET REMOTE CONTROL UNIT, SHE FELT LIKE SHE FELL ASLEEP, PASSED OUT AND WOKE UP ON THE OTHER SIDE OF THE ROAD. PT HAD STATED THIS HAD HAPPENED TO HER YEARS AGO AND THAT IS HOW SHE WAS ORIGINALLY FITTED WITH A PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591818 EPOCKET REMOTE CONTROL UNIT, HEARING INSTRUMENT ESD SIEMENS HEARING INSTRUMENTS, INC. EPOCKET NA

    Patients

    Seq Age Sex Outcome Treatment
    1