BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 2202137 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03878
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 19, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S030
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 AT THE DEVICE CHECK THE PATIENT HAD CHEST PAIN AND A HEART RATE OF 140 BEATS PER MINUTE. THE HEART RATE DECREASED WHEN THE DEVICE'S RATE RESPONSE WAS TURNED OFF. 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. E2SR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention (B)(4) IMPLANTABLE PACING LEAD