BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 2964495 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01901
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 : D274TRK IMPLANTABLE DEFIBRILLATOR (B)(6) 2010; 6947 IMPLANTABLE TACHY LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASING PHRENIC NERVE STIMULATION DUE TO THE LEFT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67348 TBD PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419378

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 4053 COMPETITOR IMPLANTABLE PACING LEAD