BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790166 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14997
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 9, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 2 WEEKS POST IMPLANT, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT (ED). AT THE TIME OF ADMISSION, THE LEAD HAD AN ELEVATED CAPTURE THRESHOLD AND IT WAS NOTED THAT THE LEAD HAD DISLODGED. IT WAS DECIDED THAT THE LEAD WOULD BE REPOSITIONED. DURING THE PROCEDURE THE PHYSICIAN INADVERTENTLY CUT THE LEAD. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB