BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2203615 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12134
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED INCREASING RIGHT VENTRICULAR (RV) THRESHOLD FOLLOWING IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. THE DEVICE WAS REPROGRAMMED, HOWEVER PATIENT CONTINUED TO HAVE INTERMITTENT LOSS OF CAPTURE (LOC). THEREFORE THE IPG WAS REMOVED AND REPLACED WITH A NEW DEVICE AND THE RV LEAD 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
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD