BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 2051624 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05601
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 30, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS HAD NO-CAPTURE. THE CINEGRAM SHOWED THAT THE LEADS HAD MOVED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEADS BUT WAS UNABLE TO FIND AN EXPECTABLE POSITION. THE LEADS WERE REMOVED AND SUCCESSFULLY REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT SECURE IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 3830 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R