BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 2883187 · Received December 21, 2012

    Report

    Report Number
    2182208-2012-04198
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 4, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    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. CONCOMITANT PRODUCT: 4965 IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE, DROPPED P WAVES AND LATE SENSING OF THE RA LEAD. IT WAS ALSO NOTED THAT THERE WAS POSSIBLE MODE SWITCHING OCCURRING. THE RIGHT VENTRICULAR (RV) LEAD WAS REPORTED AS HAVING HIGH THRESHOLDS. THE RA LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE RV LEAD REMAINS IN USE WITH A POSSIBILITY OF LEAD REVISION TAKING PLACE IN A FEW MONTHS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS RESULT OF THE NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4965-15

    Patients

    Seq Age Sex Outcome Treatment
    1 ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)