BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN LDS LEFT-HEART DELIVERY SYSTEM

    MDR report key: 4832622 · Received June 10, 2015

    Report

    Report Number
    9612164-2015-00962
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 2, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K021587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE LEAD WAS UNABLE TO BE FIXED WELL DUE TO PATIENT ANATOMY. IT WAS NOTED THAT THE LEAD DISLODGED WHILE SLITTING THE SHEATH OF THE DELIVERY CATHETER. THE PHYSICIAN ATTEMPTED TO PLACE THE LEAD MANY TIMES, BUT TO NO AVAIL. FINALLY THE PHYSICIAN ELECTED TO REMOVE AND REPLACED THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373865 ATTAIN LDS LEFT-HEART DELIVERY SYSTEM CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6216A003 0007008316

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR