BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 6628878 · Received June 8, 2017

    Report

    Report Number
    2649622-2017-07477
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    December 20, 2010
    Report Date
    April 26, 2017
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: DELIVERY CATHETER (UNKNOWN MANUFACTURER). 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.

    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 HAD DEVELOPED ¿SUSTAINED VENTRICULAR TACHYCARDIA (VT)¿ DURING THE LEAD IMPLANT PROCEDURE. THE PATIENT REQUIRED EXTERNAL CARDIOVERSION. THE LEAD APPEARS TO BE STILL 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
    408870 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R