BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 3153080 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05814
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    April 8, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. PRODUCT: 5086MRI IMPLANTABLE PACING LEAD (B)(6) 2012; RVDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S FAMILY MEMBER THAT THE PATIENT HAD A CHRONIC COUGH WHICH MAY HAVE CAUSED THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS TO BOTH COME LOOSE. SURGERY WAS PERFORMED TO REVISE THE POSITIONING OF THE LEADS. THE RA AND RV LEADS REMAIN 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
    255996 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R