BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA SR

    MDR report key: 1863152 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05081
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE BELIEVES AIRPORT SECURITY MAY HAVE INTERFERED WITH HER DEVICE. SHE WAS NOT FEELING WELL AND WAS FEELING INTERMITTENT ARRHYTHMIA SINCE GOING THROUGH THE AIRPORT SECURITY. SHE WAS UNABLE TO REACH HER DOCTOR. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADSR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other UNK IMPLANTABLE PACING LEAD