BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 1922208 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05895
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 DEVELOPED A HEMATOMA IN THE DEVICE POCKET AREA. DEVICE DETECTION WAS DISABLED DURING THE SURGICAL PROCEDURE AND THAT DURING THE PROCEDURE, THE DEVICE AUDIBLE ALERTS COULD BE HEARD. 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 MAXIMO II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 6942 IMPLANTABLE TACHY LEAD