BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3861424 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07132
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 5, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: A2DR01 IPG, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVELY THE THRESHOLD, SENSING, AND IMPEDANCE VALUES WERE NORMAL, BUT THE PATIENT COMPLAINED CONTINUOUSLY OF CHEST PAIN. ECHOCARDIOGRAM WAS PERFORMED WHICH VERIFIED THE POSSIBILITY OF A MICROPERFORATION. THE PATIENT ALSO EXPERIENCED TAMPONADE, AND SO BLOOD WAS REMOVED. THE PHYSICIAN EXPLANTED AND REPLACED BOTH LEADS. AFTER IMPLANTING THE NEW LEAD, THE RV (RIGHT VENTRICULAR) THRESHOLD CHANGED SEVERAL TIMES. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337369 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| L| R 5086MRI52 LEAD