BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN PERFORMA MRI SURESCAN

    MDR report key: 10740999 · Received October 27, 2020

    Report

    Report Number
    2649622-2020-20733
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 27, 2020
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169002715
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DTMA,1QQ CRT-D, IMPLANTED (B)(6) 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. A REPLACEMENT SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206561 ATTAIN PERFORMA MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429888 00643169002715

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R 5076-45 LEAD, 6947M55 LEAD