BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN

    MDR report key: 2865056 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17648
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. (B)(4). PRODUCT EVENT SUMMARY #(B)(4) - THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND. HOWEVER, THERE WAS BLOOD IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED). THERE WAS BLOOD IN THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN POSITIONED THE LEAD AND FOUND THAT THE PATIENT HAD DIAPHRAGMATIC STIM ULATION. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN DECIDED TO USE A DIFFERENT LEAD. THE LEAD WAS NOT USED AND A NEW 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
    1 ATTAIN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4196

    Patients

    Seq Age Sex Outcome Treatment
    1