BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT SECURE

    MDR report key: 1874767 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11548
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    July 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. EVALUATION SUMMARY: (B)(4)NO ANOMALIES FOUND, HOWEVER BLOOD WAS NOTED ON HELIX MECHANISM; FULL LEAD RETURNED AND ANALYZED. (B)(4)NO ANOMALIES FOUND, HOWEVER BLOOD WAS NOTED ON HELIX MECHANISM; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE INTRODUCER "BENT AND MADE THE LEAD DEFORMED." THIS WAS REPORTED TO HAVE HAPPENED TWICE, RESULTING IN THE PHYSICIAN CHANGING INTRODUCERS TWICE, AND THIS OCCURRED WITH BOTH LEADS. THE LEADS WERE NOT USED. 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 74 YR Required Intervention