BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIROUET+

    MDR report key: 1990624 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02099
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S3
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIROUET+ IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IMU49B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R SEDR01 IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD