BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN PERFORMA

    MDR report key: 7899669 · Received September 21, 2018

    Report

    Report Number
    2649622-2018-15534
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    February 16, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169002517
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE PATIENT EXPERIENCED CENTRAL VENOUS STENOSIS AND SUPERIOR VENA CAVA (SVC) SYNDROME DUE TO OCCLUSION OF THE B RACHIOCEPHALIC AND SCV VEINS BY THEIR RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS. THE PATIENT UNDERWENT AN ANGIOPLASTY AND HAD THEIR DIALYSIS CATHETER MOVED TO A NEW LOCATION. THE RA, RV, AND LV LEADS REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE ADAPT RESPONSE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739598 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439888 00643169002517

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R 6935M55 LEAD, 5076-45 LEAD, DTBA1QQ CRTD