BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2955451 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01366
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 5866 IMPLANTABLE LEAD ADAPTOR - 2012 (B)(6); 5071 IMPLANTABLE PACING LEAD - 2012 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SHORTNESS OF BREATH, AND BOTH OF THE EPICARDIAL VENTRICULAR LEADS WERE FOUND TO EXHIBIT INCREASED THRESHOLDS, AS WELL AS A LOSS OF CAPTURE DURING THRESHOLD TESTING. THE LEADS WERE REPROGRAMMED, AND REMAIN 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
    59001 SCREW-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER