BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2864789 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17514
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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. (B)(4). CONCOMMITANTS PRODUCTS: 5076 PACING LEAD, (B)(6) 2004, ADDR01: IMPLANTABLE PULSE GENERATOR; IMPLANT DATE (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POLARITY SWITCH ON THE VENTRICULAR LEAD DUE TO HIGH IMPEDANCE. OVERSENSING OCCURRED WHEN THE LEAD SWITCHED TO UNIPOLAR. THE LEAD WAS SWITCHED BACK TO UNIPOLAR AND WILL BE MONITORED. THE LEAD IS STILL 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
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention