BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY MRI SURESCAN

    MDR report key: 3151781 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05624
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    November 19, 2019
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 1580, COMPETITOR IMPLANTABLE TACHY LEAD, (B)(6) 2004; 1688T, COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PHRENIC NERVE STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253224 ATTAIN ABILITY MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (I