BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2840320 · Received November 20, 2012

    Report

    Report Number
    2182208-2012-04041
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 8, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IMPLANTABLE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS BEEN CAUSING VENTRICULAR BEATS. THE LEAD REMAINS IN USE AND WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 4965 IMPLANTABLE PACING LEAD