BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1991965 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02654
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THERE WAS AN INFECTION AT THE INCISION SITE. THE LEAD WAS REMOVED AND THE PATIENT WAS PLACED ON TOPICAL ANTIBIOTICS. AFTER NO IMPROVEMENT, THE INCISION WAS EXPLORED AND TWO SUPERFICIAL ABCESSES WERE FOUND NEAR THE RING OF THE LEFT VENTRICULAR LEAD. NO GROWTH WAS NOTED ON THE CULTURE. A NEW LEAD WAS THEN IMPLANTED IN A NEW LOCATION. NO FURTHER PATIENT COMPLICATIONS WERE 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. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD