BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 6628813 · Received June 8, 2017

    Report

    Report Number
    2649622-2017-07476
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    June 3, 2011
    Report Date
    April 26, 2017
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND SUBSEQUENT FOLLOW UP INFORMATION OBTAINED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. REFERENCED ARTICLE: ¿REAL-WORLD ASSESSMENT OF ACUTE LEFT VENTRICULAR LEAD IMPLANT SUCCESS AND COMPLICATION RATES: RESULTS FROM THE ATTAIN SUCCESS CLINICAL TRIAL.¿ PACE 2016; 39:1246¿1253. DOI: 10.1111/PACE.12939. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT¿S IMPLANTED PACING LEAD. FOLLOW UP WAS CONDUCTED AND IT WAS DETERMINED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC PACING FOR TWO DAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE LEFT VENTRICULAR (LV) LEAD WAS FOUND NOT PACING AND HAD DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408603 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R