BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT SR

    MDR report key: 3033380 · Received April 3, 2013

    Report

    Report Number
    2017865-2013-01687
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PULSE GENERATOR WAS ORIGINAL SUBMITTED ON APRIL 5, 2013 NOTING MODEL AS PM2110, SN (B)(4). WE HAVE SINCED LEARNED THAT THE MODEL WAS PM1110, SN (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136118 ACCENT SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death