BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3801301 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10984
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR SUSPECTED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278782 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3213-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1