BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS LEAD

    MDR report key: 3153588 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06115
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K940703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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: KDR901 IMPLANTABLE PULSE GENERATOR (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD NO CAPTURE. THE LEAD WAS CAPPED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259148 TRANSVENOUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4558M45

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R