BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 3153371 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05979
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: D284TRK, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2001; 5076-52, IMPLANTABLE PACING LEAD, (B)(6) 2002; 694765, IMPLANTABLE TACHY LEAD, (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD MEASURED HIGH THRESHOLD VALUES. THE LEAD WAS CAPPED AND WAS REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258197 TBD PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419378

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R