BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT SECURE

    MDR report key: 2810473 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15996
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 4, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEAD THE PHYSICIAN WAS UNABLE TO GET GOOD THRESHOLDS AFTER MULTIPLE ATTEMPTS. IT WAS ALSO REPORTED THAT THE SHEATH COULD NOT REACH THE TARGET POSITION AND THE LEAD DISTORTED, SO THE LEAD WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other