BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2952025 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00396
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    April 25, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PRODUCT EVENT SUMMARY: THE LEAD IN SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE PROXIMAL AND DISTAL CONDUCTOR WAS DISTORTED KINKED/BUCKLED AND HAD BLOOD NOT OBSTRUCTED. THE LEAD OUTER INSULATION WAS BREACH/CUT, MELTED AND HAD COSMETIC DEPRESSION. THE LEAD HAD APPARENT EXPLANT DAMAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE LEFT VENTRICULAR (LV) LEAD WAS FLUSHED WITH SALINE A HOLE WAS NOTED ABOUT ONE THIRD OF THE WAY DOWN FROM THE CONNECTION POINT. THEREFORE THE LV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57720 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER CARDIO/DEFIB