BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2964850 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02053
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 7, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PRODUCT: 6932 IMPLANTABLE TACHY LEAD (B)(6) 1997. (B)(4). LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE REPORTED THAT THERE WAS A "MALFUNCTION" OF THE LV (LEFT VENTRICULAR) LEAD. FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67259 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR