BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2790022 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14694
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 29, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 VENTRICULAR [RV] LEAD DISLODGED. DURING THE REVISION, THE PHYSICIAN REPOSITIONED THE RV LEAD. AFTER IT WAS REPOSITIONED, THE HELIX WOULD NOT EXTEND. THE PHYSICIAN THEN PULLED THE LEAD BACK AND TURNED THE HELIX "MANY TIMES AND IT FINALLY EXTENDED." THE PHYSICIAN THEN RETRACTED THE HELIX WITH SOME DIFFICULTY AND ATTEMPTED TO REPOSITION THE RV LEAD; HOWEVER, THE STYLET WAS THEN UNABLE TO BE PLACED IN THE LEAD. THE LEAD WAS REMOVED AND A DIFFERENT 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB