BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3791064 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10339
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 5, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED TELEMETRY ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHECKS, PACING SPIKES WERE OBSERVED AT A RATE OTHER THAN THE PROGRAMMED ICD BASE RATE. THE NATURE OF THE SPIKES COULD NOT BE DETERMINED. THE PATIENT HAD A PREVIOUSLY IMPLANTED PACEMAKER PROGRAMMED OUT OF SERVICE. THE ICD WAS ELECTIVELY REPLACED WITH A NEW PACEMAKER DUE TO A CHANGE IN THE PATIENTS INDICATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268045 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR