BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 1924437 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06138
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 4, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 PATIENT "HAD SHORTNESS OF BREATH AND DIDN'T FEEL WELL." THE DEVICE INDICATED ELECTIVE REPLACEMENT AND WAS EXPLANTED AND REPLACED. NO FURTHER 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. E2DR21 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R 5076X2 IMPLANTABLE PACING LEAD