BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 4832726 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07422
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, TWO DIFFERENT LEFT VENTRICULAR LEADS WERE ATTEMPTED, BUT COULD NOT BE PLACED AND SECURED. NO LEFT VENTRICULAR LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374517 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429888

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR