BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPULSE

    MDR report key: 2123828 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02300
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER COULD NOT GET A CONSISTENT MAGNET RESPONSE WITH PATIENT TRYING TO TRANSMIT ELECTROCARDIOGRAM (ECG) DURING TRANSTELEPHONIC MONITORING. THE CALLER WANTED TO MAKE SURE THE PATIENT HAD A PACER, NOT AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD). IT WAS CONFIRMED THAT THE PATIENT HAS A PACEMAKER AND NOT AN ICD. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E2DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other 5068 X2 IMPLANTABLE PACING LEADS