BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3153258 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05915
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE LEAD COULD NOT BE IMPLANTED DUE TO ANATOMY AND PHRENIC NERVE STIMULATION. THE LEAD WAS NOT USED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256080 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR