BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 1991082 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02248
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    September 8, 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
    MD, 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): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD NO CAPTURE, UNDERSENSING AND DIFFICULTY WITH POSITIONING/FIXATION. THE LEAD WAS DISLODGED. IT 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 82 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 3830 IMPLANTABLE PACING LEAD