BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2952397 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00565
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCTS: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2004; 5076 IMPLANTABLE PACING LEAD (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED AN INFECTION OCCURRED. DURING LEAD REMOVAL, PUS WAS REPORTED TO BE IN THE POCKET AND THE CAPSULE WAS GROSSLY INFECTED. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57539 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR