BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 3863411 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06738
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 3, 2012
    Report Date
    April 6, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POST IMPLANT, THE PATIENT DEVELOPED A HEMATOMA AT THE POCKET SITE. THE HEMATOMA WAS DRAINED AND THE LEADS REMAIN IN USE. THE PATIENT WAS ENROLLED IN A POST MARKET CLINICAL 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
    340957 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention 2872 LEAD