BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMA PA

    MDR report key: 3482223 · Received November 14, 2013

    Report

    Report Number
    3005019184-2013-00002
    Event Type
    Injury
    Date Received
    November 14, 2013
    Date of Event
    July 22, 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: THE DEVICE WHICH ALLEGEDLY CAUSED THE INCIDENT WAS REPLACED AND DISPOSED OF PRIOR TO THE PT NOTIFYING SIEMENS ABOUT THE INCIDENT. AS A RESULT, IT COULD NOT BE ASSESSED. WE RECEIVED THE REPLACEMENT DEVICE FROM THE PT, BUT THIS HAD NO RELATION TO THE INCIDENT. THE ORIGINAL HEARING AID WAS BUILD IN 08/2002 AND WAS REPAIRED IN 2006. THE RECORDED REPAIR DIAGNOSIS IN 2006 WAS THAT THE RECEIVER TUBE AND AUDIO INPUT WERE DAMAGE AND THE MICROPHONE WORN. THE HIGHEST VOLTAGE IN THE DEVICE IS 1.4 V DC AND THE HIGHEST POSSIBLE CHARGE IS LESS THAN 20UW. BASED ON THIS AND THE TECHNOLOGY USED IN THE DEVICE IT WAS DETERMINED THAT A CAUSAL RELATIONSHIP BETWEEN THE SYMPTOMS REPORTED BY THE PT AND THE DEVICE COULD BE EXCLUDED, AND THAT THE PRODUCT COULD NOT HAVE CONTRIBUTED TO THE HEALTH EFFECTS IN THE CONTEXT OF THIS INCIDENT, EVEN IF DEFECTIVE.

    Description of Event or Problem · 1

    IN A LETTER THE PT CLAIMED THAT SHE FELT ELECTRICAL SHOCKS ON HER LEFT EAR WHILE WEARING PRISMA P BTE. SHE SUFFERED FROM SWELLING, REDNESS AND PAIN ON AND AROUND THE EAR AND WAS ADMITTED TO A HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591161 PRISMA PA BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention