BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 3071823 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05271
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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: 4076 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, WHILE ATTEMPTING TO SUB-SELECT A SPECIFIC CORONARY SINUS VEIN, THE PHYSICIAN DISSECTED THE CORONARY SINUS BODY. LATER, TWO LEFT VENTRICULAR (LV) LEADS WERE ATTEMPTED TO BE USED, BUT THE GUIDEWIRE LOCKED UP IN THE LEADS DURING LEAD PLACEMENT. THERE WAS A LOT OF RESISTANCE AND FRICTION WHILE MOVING THE GUIDEWIRE THROUGH THE LEADS. THE PHYSICIAN BELIEVED THAT BOTH OF THE LEADS WERE FLUSHED WITH A HALF-SALINE, HALF-CONTRAST SOLUTION PRIOR TO IMPLANT. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171527 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR 6947 IMPLANTABLE TACHY LEAD