BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2071177 · Received April 27, 2011

    Report

    Report Number
    2649622-2011-07336
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 14, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SIX WEEKS AFTER DEVICE IMPLANT. THERE WAS A QUESTION REGARDING DEVICE UNDERSENSING. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THE PATIENT HAD A HISTORY OF CLASS LV HEART FAILURE WITH A NUMBER OF ARRHYTHMIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY PLUS IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4296 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death