BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 2812713 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16465
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 25, 2012
    Report Date
    January 3, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) - THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, WAS ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THE OUTER INSULATION WAS MELTED, THE DISTAL AND PROXIMAL CONDUCTORS WERE KINKED/BUCKLED, THE LEAD WAS STRETCHED AND THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE AND LEADS WERE REMOVED DUE TO BACTEREMIA. THE ORGANISM IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE AND LEADS WERE REMOVED DUE TO BACTEREMIA. THE ORGANISM IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4196

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R