BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 3990998 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08385
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 IMPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY OBTAINING CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD. NUMEROUS POSITIONS WERE ATTEMPTED WITH SOME CAPTURE ACHIEVED, HOWEVER, THE POSITIONS WERE NOT CLINICALLY ACCEPTABLE. LV LEAD PLACEMENT WAS ABANDONED. THE PHYSICIAN CHOSE TO CUT AND CAP THE LV LEAD IN ORDER TO FASHION A PORT PLUG FOR THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471625 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429888

    Patients

    Seq Age Sex Outcome Treatment
    1