BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3071785 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05303
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 ID: (B)(4) IMPLANTABLE PACING LEAD 1999 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAVE BEEN ATRIAL LEAD WARNINGS FOR SOME TIME. THE ATRIAL LEAD SENSING HAS BEEN DISCUSSED SINCE IMPLANT AND PROGRAMMING CHANGES WERE MADE. THE RIGHT VENTRICULAR LEAD WAS OVERSENSING NOISE AND WAS REPROGRAMMED. THE LEAD CONTINUES TO HAVE OVERSENSING. BOTH THE ATRIAL AND RIGHT VENTRICULAR LEADS ARE 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
    172311 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR