BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3062214 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05097
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. DEVICE: C4TR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2012-12; 50760 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD WHICH WAS RESOLVED BY CHANGING THE LV PACING CONFIGURATION. ALSO, THE DEVICE WHICH HAD ONLY BEEN IMPLANTED APPROXIMATELY TWO AND A HALF MONTHS WAS INDICATING DEVICE LONGEVITY OF TWO YEARS. THE LV LEAD AND DEVICE BOTH REMAIN 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
    162842 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429678

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention