BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2952029 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00419
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD ON THE DISTAL CONDUCTOR, THE OUTER INSULATION WAS BREACHED CUT, THE HELIX WAS DISTORTED/BENT, THE HELIX APPEARS TO HAVE BEEN PULLED/STRETCHED/OVERSTRESSED AND THERE WAS APPARENT EXPLANT DAMAGE. CONCOMITANT MEDICAL PRODUCTS: RVDR01 IMPLANTABLE PULSE GENERATOR: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DISLODGED SHORTLY AFTER IMPLANT. THE DISLODGEMENT WAS FOUND ON X-RAY THE NEXT MORNING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55661 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 00067 YR Hospitalization| R 5086MRI IMPLANTABLE PACING LEAD