BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 7772641 · Received August 10, 2018

    Report

    Report Number
    2649622-2018-13104
    Event Type
    Injury
    Date Received
    August 10, 2018
    Date of Event
    June 1, 2018
    Report Date
    August 10, 2018
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00613994469724
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MDT-CRT-D. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE DEVICE AND LEADS WERE REMOVED AND SUBSEQUENTLY REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613492 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678 00613994469724

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 5076-52 LEAD, 0180 LEAD