BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2955569 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01498
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT PRODUCTS 5076 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON TELEMETRY THE PATIENT'S RATE WAS INTRINSIC IN THE 40'S WHEN THE DEVICE WAS PROGRAMMED TO A LOWER RATE OF 60. IT WAS ALSO REPORTED THAT THE VENTRICULAR CAPTURE MANAGEMENT TREND WAS VARYING, AND THAT THERE WERE HIGH THRESHOLDS AT IMPLANT. IT WAS NOTED THAT THE PATIENT IS CURRENTLY IN ATRIAL FIBRILLATION (AF), HAS BEEN ON DIALYSIS, AND THERE HAS BEEN A CHANGE IN MEDICATIONS, CONTRIBUTING TO LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. CAPTURE MANAGEMENT WAS TURNED OFF AND OUTPUTS WERE SET TO MAXIMUM. CAPTURE WAS OCCURRING AT THE PROGRAMMED OUTPUT. THE RV LEAD REMAINS IN USE WITH CONTINUED MONITORING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59154 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

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