BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2955445 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01420
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 6, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 PRODUCTS: 5023M IMPLANTABLE PACING LEAD: (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE REPLACEMENT, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD IMPEDANCE WAS LOW. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58999 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R 7068B IMPLANTABLE PULSE GENERATOR (IPG)