BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2952331 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00504
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PRODUCT: 6947, IMPLANTABLE TACHY LEAD 2008-(B)(6). CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2008-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COMPARISON OF THE USE BEFORE DATE (UBD) FIELD AND IMPLANT DATE OF THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE IMPLANTED AFTER THE UBD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57340 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR C154DWK IMPLANTABLE PACEMAKER CARDIO/DEFIB