BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1791743 · Received August 10, 2010

    Report

    Report Number
    2182208-2010-00428
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    September 1, 2007
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    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 THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DURING NORMAL EXERTION ON 2 OCCASIONS IN ONE WEEK. UPON EXAMINATION, IT WAS DISCOVERED THE LEAD HAD "DETACHED FROM THE HEART QUITE SIGNIFICANTLY". SURGERY WAS PERFORMED TO REATTACH THE LEAD. 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, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S D154VWC IMPLANTABLE PACEMAKER/CARDIO/DEFIB