BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 4162479 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12759
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 5, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. CONCOMITANT MEDICAL PRODUCTS: 5076 LEAD, IMPLANTED: (B)(6) 2007; 4076 LEAD, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION WHILE ATTEMPTING TO PLACE THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN ATTEMPTED TO PLACE THE LEAD IN A LOCATION WITHOUT STIMULATION, BUT WAS UNABLE TO DUE TO INSUFFICIENT STABILITY. THE LEAD WAS NOT USED AND THE DECISION WAS MADE NOT TO PLACE AN LV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640546 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR 1291 IPG