BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2203329 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04172
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE PATIENT'S SON QUESTIONED IF THE DEFIBRILLATOR WAS ON RECALL. THE PATIENT HAD EXPERIENCED HEART FAILURE AND REQUIRED RESCUE FROM THE PARAMEDICS. THE PATIENT IS NOW HOSPITALIZED WITH BRAIN DAMAGE AND UNTIL RECENTLY WAS ON LIFE SUPPORT. THE DEFIBRILLATOR REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD