BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 6162676 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-15321
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    September 30, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169601789
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    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 DURING ATTEMPTED IMPLANT THE LEFT VENTRICULAR (LV) LEAD DISLODGED MULTIPLE TIMES. A REPLACEMENT LV 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
    812034 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429678 00643169601789

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR