BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA VR

    MDR report key: 4161840 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19000
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HEARING AN ALARM FROM THE DEVICE. THE PATIENT ALSO REPORTS HAVING PAIN IN THEIR LEFT NECK AND ARM/DEVICE AREA. FOLLOW-UP WAS CONDUCTED TO OBTAIN INFORMATION ON THE PATIENT AND WHETHER THE EPISODE WAS DEVICE RELATED, BUT THE ATTEMPTS WERE UNSUCCESSFUL. RECORDS INDICATE THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639567 SECURA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR 6947 LEAD