BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810932 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16071
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 PATIENT WAS EXPERIENCING PALPITATIONS FROM THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO STATED BY THE PATIENT THAT THERE WAS SOMETHING WRONG WITH THE RV LEAD AND IT NEEDED TO BE EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE WAS "MOVING" OR "TURNING" AND WILL ALMOST STAND UP ON END WHEN THE PATIENT IS LYING ON THEIR SIDE. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED THROUGH FOLLOW UP AND THE DEVICE REMAINS IN USE. NO FURTHER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 4469 COMPETITOR IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD