BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY MRI

    MDR report key: 6508650 · Received April 20, 2017

    Report

    Report Number
    2017865-2017-02449
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 5, 2017
    Report Date
    October 2, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    DXY
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA/510K # SHOULD HAVE BEEN P140033 RATHER THAN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS HOME ON (B)(6) 2017 HE EXPERIENCED CHEST PAIN. HE PRESENTED TO THE HOSPITAL WERE HIS DEVICE WAS REPROGRAMMED. THE PATIENT'S PAIN DECREASED OVER A FEW DAYS AND HE WAS SENT HOME WITHOUT A CLEAR DIAGNOSIS. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290335 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 P000037014

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 2088TC/52 CNY286202| 2088TC/58 CPA356143