BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3151744 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01271
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 26, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    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. CONCOMITANT MEDICAL PRODUCTS: D224TRK, BI-VENTRICULAR DEFIBRILLATOR, (B)(6) 2009; 5076-52, IMPLANTABLE PACING LEAD; 6949-65, IMPLANTABLE TACHY LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE OFFICE VISIT INHIBIT TEST, THERE WAS DOUBLE COUNTING OF THE R-WAVE EVERY 3RD TO 5TH BEAT. IN THE PAST THE LEFT VENTRICULAR LEAD WAS SWAPPED IN THE HEADER WITH THE RIGHT VENTRICULAR PACE SENSE CONDUCTOR. ADDITIONALLY, SENSING HAD BEEN PROGRAMMED TO INTEGRATED BI-POLAR. SENSING WAS REPROGRAMMED TO BI-POLAR AND THE DOUBLE COUNTING WAS NOT SEEN. 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
    252338 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-60

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R