BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 1923173 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13286
    Event Type
    Injury
    Date Received
    December 13, 2010
    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
    VT, 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) PRELIMINARY ANALYSIS REVEALED TIP ELECTRODE MISCELLANEOUS (NON-ELECTRICAL). THE FULL LEAD WAS RETURNED AND ANALYZED. FURTHER TESTING REVEALED BLOOD IN/ON THE HELIX MECHANISM. THE LEAD WAS RETURNED WITH TISSUE ON THE HELIX WHICH MOST LIKELY CONTRIBUTED TO THE REPORTED ELECTRICAL ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD LOSS OF CAPTURE AND HIGH THRESHOLDS. THE LEAD WAS REMOVED AND 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 76 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR