BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 4061839 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15514
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED ERI NOTIFIER ANOMALY WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE VERIFIED THE BATTERY VOLTAGE WAS BELOW ERI PRIOR TO EXPLANT WITHOUT TRIGGERING AN ERI ALERT. FURTHER INVESTIGATION INDICATED THERE WAS A MANUFACTURING ANOMALY WHICH CAUSED TO DEVICE TO HAVE A LOWER THAN EXPECTED VOLTAGE THRESHOLD FOR ERI. THE CAUSE OF THE FIELD EVENT WAS DUE TO A MANUFACTURING ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS AT ERI BUT ERI WAS NOT DISPLAYED ON REMOTE TRANSMISSIONS, AND THE PATIENT DID NOT RECEIVE A PATIENT NOTIFICATION ALERT. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. THE PATIENT CONDITION WAS GOOD FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540461 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR