BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 3153219 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05884
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 18, 2013
    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
    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: 5071-53, IMPLANTABLE PACING LEAD, (B)(6) 2012; 4076 X 2, IMPLANTABLE PACING LEADS, (B)(6) 2012; C4TR01, IMPLANTABLE PULSE GENERATOR, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO EPICARDIAL LEFT VENTRICULAR LEADS AND BOTH LEADS HAD HIGH THRESHOLDS. THE LEADS WERE CAPPED AND A TRANSVENOUS LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256030 SCREW-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R