BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 3861995 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07106
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. PRODUCTS: (B)(4) ICD; 6947 LEAD, IMPLANTED 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A RASH ABOUT THREE WEEKS AFTER THE DEVICE WAS REPLACED AND A NEW LEAD WAS IMPLANTED. THE PATIENT HAS HIVES AROUND THE AREA OF THE IMPLANT WHICH HAS SPREAD EVERYWHERE AND THEY ARE FEELING MISERABLE. THE PATIENT ALSO STATED THAT THIS MAY BE RELATED TO A CHANGE IN MEDICATIONS. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337988 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR 4558M53 LEAD