BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2953741 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01315
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) IMPLANTABLE PULSE GENERATOR (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED CHEST PAIN AFTER IMPLANT OF THE PACING SYSTEM. ALL VALUES WERE NORMAL, ECHOCARDIOGRAM AND COMPUTERIZED TOMOGRAPHY (CT) SCAN WERE NORMAL. ACCORDING TO THE PHYSICIAN THERE WAS NO EVIDENCE OF LEAD PERFORATION. THE PHYSICIAN ELECTED TO PROPHYLACTICALLY REPOSITION THE RIGHT VENTRICULAR LEAD AS HE SUSPECTED THAT THERE COULD BE A "MICRO-PERFORATION." THE LEAD WAS REPOSITIONED AND 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
    57434 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 00088 YR Hospitalization| R 5086MRI IMPLANTABLE PACING LEAD