BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT SECURE

    MDR report key: 1854967 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09187
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM. (B)(4) NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE ATRIAL LEAD COULD NOT BE IMPLANTED DUE TO THE PATIENT'S ANATOMY, AND THE VENTRICULAR LEAD BEING USED DISLODGED, ALSO DUE TO THE PATIENT'S ANATOMY. BOTH LEADS WERE NOT USED AND WERE 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 77 YR Required Intervention