BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2812726 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16694
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006/S004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY BREATHING AND PAIN IN THE CHEST AND SHOULDER. AN ECHOCARDIOGRAM CONFIRMED PERICARDIAL TAMPONADE. THE PATIENT UNDERWENT A SURGICAL INTERVENTION. THE LEADS REMAIN 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
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4396

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB