BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI

    MDR report key: 3071660 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05243
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. (B)(4). (B)(4) IMPLANTABLE PACING LEAD 2012 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH, UNSTABLE THRESHOLDS AND THE PATIENT EXPRESSED DISCOMFORT WHILE BEING PACED IN THE RIGHT VENTRICLE. THE LEAD WAS REPOSITIONED TO ACHIEVE APPROPRIATE THRESHOLDS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172069 CAPSUREFIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R RVDR01 IMPLANTABLE PULSE GENERATOR