BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2123914 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08201
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    January 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DURING IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE LEAD DISLODGED DURING THE SLITTING PROCESS, AND THERE WAS DIFFICULTY IN PLACING THE LEAD DUE TO ACCESS PROBLEMS AND THE PATIENT'S ANATOMY. THEREFORE THE DECISION WAS MADE TO ABANDON THE LV LEAD AND HAVE A LEAD IMPLANTED EPICARDIALLY. NO 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. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 5076 IMPLANTABLE PACING LEAD| (B)(4) TISSUE VALVE| 5054 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB