BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRINSIC

    MDR report key: 1990395 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00721
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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 THERE WAS A REQUEST TO TURN OFF THE IMPLANTABLE CARDIAC DEFIBRILLATOR ON THIS HOSPICE PATIENT DUE TO THE PATIENT RECEIVING THERAPY. THE DEVICE WAS UNABLE TO BE INTERROGATED. IT WAS FURTHER REPORTED THAT A MAGNET WAS PLACED ON THE DEVICE TO SUSPEND THERAPY. 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 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD