BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 4163455 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12320
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 THE RIGHT VENTRICULAR (RV) LEAD HAD A SUDDEN RISE IN IMPEDANCE TO HIGH LEVELS. THRESHOLDS HAD ALSO INCREASED, AND FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. A NEW DEVICE WITH ADDITIONAL VECTORS WAS IMPLANTED TO MITIGATE THE STIMULATION. THE LV LEAD REMAINS 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
    640405 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R 8042B IPG, 5076-45 LEAD, 5076-52 LEAD