BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2954595 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02304
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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: 6947 IMPLANTABLE TACHY LEAD 2003 (B)(6); 5076 IMPLANTABLE PACING LEAD 2003 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD TRIGGERED A LEAD WARNING FOR HIGH IMPEDANCE. THE LEAD WAS EXPLANTED 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
    59704 SCREW-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-35

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR