BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3992686 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09734
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. CONCOMITANT PRODUCTS: 4076-52 LEAD IMPLANTED (B)(6) 2013; DTBA1D1 ICD IMPLANTED (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T-WAVE OVERSENSING WAS OBSERVED DURING LEFT VENTRICULAR (LV) AND BI-V PACING. IN ADDITION, DIAPHRAGMATIC STIMULATION WAS IDENTIFIED DURING THE PATIENT'S VISIT TO THE CLINIC. REPROGRAMMING WAS DONE FOR THE LEFT VENTRICLE AND RIGHT VENTRICLE LEADS. THE LEADS 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
    469460 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention 6935-65 LEAD