BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1803251 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08832
    Event Type
    Injury
    Date Received
    August 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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 ATRIAL LEAD DISLODGED. THE SAME LEAD WAS REPOSITIONED AND REMAINS IN USE. ADDITIONAL INFORMATION RECEIVED REPORTED THE RIGHT VENTRICULAR (RV) LEAD WAS NOT IN ITS PROPER POSITION. DURING THE TIME OF THE RIGHT ATRIAL LEAD REPOSITIONING, THE CRT-D AND RV LEAD WERE REPOSITIONED WITH MODIFICATION OF LEAD/HEADER CONNECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention NON-MEDTRONIC IMPLANTABLE PACING LEAD