BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2953694 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01246
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 2, 2012
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. PRODUCT EVENT SUMMARY #(B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. NO ANOMALIES WERE FOUND. THE LEAD INSULATION HAD COSMETIC (EXTRINSIC) OUTER INSULATION CUT. THE LEAD INSULATION HAD COSMETIC (IN-VIVO) OUTER INSULATION DEPRESSION. THE LEAD CABLE/COIL CONDUCTOR WAS NOT OBSTRUCTED AT LV2/PROXIMAL WITH BLOOD. THE LEAD CABLE/COIL CONDUCTOR WAS DISTORTED (EXTRINSIC) AT THE LV2/PROXIMAL WITH KINKED/BUCKLED. THE LEAD INSULATION WAS BREACH (EXTRINSIC) WITH AN OUTER INSULATION CUT. THE LEAD CABLE/COIL CONDUCTOR WAS NOT OBSTRUCTED AT LV1/DISTAL WITH BLOOD. VISUAL ANALYSIS NOTED THE LEAD HAD APPARENT EXPLANT DAMAGE. CONCOMITANT CONTINUED: (B)(4), IMPLANTABLE PACING LEAD, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTION. THE ATRIAL LEAD WAS EXPLANTED AND WAS SUBSEQUENTLY REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55741 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR