BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 4162990 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12532
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE PROXIMAL AND DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE LEAD WAS RETURNED WITH THE GUIDEWIRE STUCK IN THE LEAD. THERE WAS A LARGE AMOUNT OF BLOOD INGRESS INTO THE LUMEN DURING THE ATTEMPTED IMPLANT, AND IT IS LIKELY THAT THE GUIDEWIRE BECAME STUCK WHEN THE BLOOD DRIED, PREVENTING ANY FURTHER MOVEMENT OF THE GUIDEWIRE. WHEN THE GUIDEWIRE WAS REMOVED DURING ANALYSIS THE COIL ON THE ¿FLOPPY¿ END WAS UNWOUND. GUIDEWIRE INSERTION TEST WAS PERFORMED WITH NEW GUIDEWIRE WITHOUT DIFFICULTY OR RESISTANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE GUIDEWIRE WAS STUCK IN THE LEAD. ANOTHER 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
    639552 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439888

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR