BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2951985 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00341
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 11, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. EVALUATION SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE PULSE GENERATOR 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED LESS THAN A MONTH AGO AND SINCE THEN THE THRESHOLDS HAD INCREASED AND THE IMPEDANCE HAD DECREASED. THERE WAS A VENTRICULAR HIGH RATE EPISODE THE DAY OF IMPLANT WHICH MAY HAVE BEEN THE RV LEAD DISLODGING. THE RV LEAD WAS STILL IN THE VENTRICLE BUT MAY HAVE PULLED BACK. THE PHYSICIAN DECIDED TO REPLACE THE LEAD VERSUS REPOSITIONING IT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55414 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 00085 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD