BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STABILITY QUAD MRI SURESCAN

    MDR report key: 12431666 · Received September 7, 2021

    Report

    Report Number
    2649622-2021-18118
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 7, 2021
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169860421
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DTMA,1QQ CRT-D, IMPLANTED: (B)(6) 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS AND POSSIBLE LOSS OF CAPTURE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330251 ATTAIN STABILITY QUAD MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MPRI 479888 00643169860421

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 5076-52 LEAD, 6935M62 LEAD