BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3153299 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05928
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. 5826 IMPLANTABLE PULSE GENERATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD FOUR SECOND PAUSES RECORDED AND NO PACING SPIKES WERE NOTED ON THE ELECTROCARDIOGRAM. THIS WAS THOUGHT TO BE OVERSENSING. THE LEAD WAS FOUND TO HAVE STABLE CAPTURE AND IMPEDANCE. ISOMETRIC AND POCKET MANIPULATION WAS UNABLE TO SOLICIT NOISE. THERE WAS NO KNOWN SOURCES OF ELECTROMAGNETIC INTERFERENCE NOTED. THE DEVICE WAS PROGRAMMED TO VOO UPIPOLAR. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256178 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4068 IMPLANTABLE PACING LEAD