BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1072049 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03829
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    February 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: IT WAS REPORTED THE LEAD WAS FRACTURED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED, REPORTING THE LEAD HAD HIGH IMPEDANCE. NO CONCLUSION CAN BE DRAWN. IMPEDANCE, HIGH, LEAD(S), FRACTURE OF.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS FRACTURED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED, REPORTING THE LEAD HAD HIGH IMPEDANCE.

    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 Required Intervention 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB