BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 6162023 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-14966
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    October 3, 2016
    Report Date
    July 31, 2020
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169601833
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED RETRACTING THE ATTEMPTED LEFT VENTRICULAR (LV) LEAD THROUGH THE VASCULATURE DURING REPOSITIONING. THE LEAD WAS REMOVED FROM THE PATIENT AND A FOREIGN BODY WAS SEEN LODGED IN THE TIP OF THE LEAD. A NEW LEAD WAS THEN PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811997 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429888 00643169601833

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR