BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPULSE

    MDR report key: 1873728 · Received September 30, 2010

    Report

    Report Number
    2647346-2010-00532
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS REPORT IS FILED UNDER EXEMPTION (B)(4) FOR A 2 YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS WHERE THE PRODUCT REMAINED IN USE; DATE RANGE MARCH 30, 2008 AND MARCH 29, 2010. THIS MEDWATCH REPORT REPRESENTS 1 OF 738 EVENTS (EVENT TYPE CODE MALFUNCTION). 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 DEVICE MOVES AROUND INSIDE THE PATIENT. THE DEVICE REMAINS IMPLANTED AND IN USE; THERE ARE NO FURTHER PATIENT COMPLICATIONS RECORDED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR/DXY DXY MEDTRONIC MED REL, INC. R1DR21

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other (2) 4965 IMPLANTABLE PACING LEAD | (2) 4965 IMPLANTABLE PACING LEAD