BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI

    MDR report key: 2953226 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00974
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 25, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PRODUCTS : (B)(4), IMPLANTABLE PACING LEAD, (B)(6) 2012; (B)(40, MECHANICAL VALVE, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS WERE "PULLED BACK" AND THE ATRIAL LEAD HAD DROPPED INTO THE VENTRICLE. IT WAS ALSO NOTED THAT THE DEVICE WAS TURNED IN THE POCKET. THE PHYSICIAN STATED THIS WAS A RESULT OF TWIDDLER'S SYNDROME. THE LEAD WERE REPOSITIONED AND 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
    55671 CAPSUREFIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER