BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3152526 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06761
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: PRODUCT ID 693565, IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2012; 5076, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012; D314TRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD. THE DEVICE WAS REPROGRAMMED TO CAPTURE ONLY ON THE RIGHT VENTRICLE (RV). IT WAS ALSO REPORTED THERE WAS AN ALERT FOR HIGH IMPEDANCE ON THE HIGH VOLTAGE "B" (HVB) COIL OF THE RV LEAD. 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
    252074 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention