BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2955125 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01008
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    February 25, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE FULL LEAD WAS RETURNED AND ANALYZED. THE LEAD DISTAL CONDUCTOR WAS KINKED AND BUCKLED. THE PROXIMAL CONDUCTOR WAS ALSO KINKED AND BUCKLED AND IT WAS VISUALLY NOTED THAT THERE WAS IMPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, DURING A REPOSITIONING ATTEMPT OF THE LEFT VENTRICULAR (LV) LEAD, NEITHER THE STYLET NOR A GUIDEWIRE WOULD PASS BEYOND APPROXIMATELY TWENTY CENTIMETERS. THE LEAD WAS REMOVED, AND A DIFFERENT LV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58872 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR