BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2954429 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02420
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THERE WAS A SET SCREW IN THE CONNECTOR BORE WHEN THE DEVICE WAS RECEIVED. CONCOMITANT MEDICAL PRODUCTS: 1580 COMPETITOR IMPLANTABLE TACHY LEAD: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT THE LEAD WOULD NOT ADVANCE FULLY INTO THE CONNECTOR. IT WAS REPORTED THAT IT SEEMED LIKE THERE WAS AN IRREGULARITY IN THE CONNECTOR PORT PREVENTING FULL INSERTION OF THE LEAD AND CAUSING A LOOSE CONNECTION. THE DEVICE WAS NOT USED AND 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
    58057 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR 1488T COMPETITOR IMPLANTABLE PACING LEAD