BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2051523 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05585
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 LEAD HAD LOW IMPEDANCE ON THE DISTAL COIL. RECENT RESULTS SHOW IMPEDANCE WITHIN NORMAL OPERATING RANGES. IT WAS ALSO REPORTED THAT THE PATIENT WAS IN THE DOCTOR'S OFFICE FOR A HEART CATHETER WHEN THE DOCTORS FOUND "THE LEADS WERE NOT IN THE PROPER PLACE." THE DOCTORS WERE ABLE TO CORRECT THE ISSUE AND DID NOT REQUIRE AN INCISION OR IMPLANTATION OF ANY NEW LEAD. THE PATIENT'S FAMILY MEMBER WAS CONCERNED THAT THE DEVICE "WOULD NOT HAVE WORKED PROPERLY" IF THE PATIENT HAD AN ARRHYTHMIA. FOLLOW-UP INFORMATION FROM THE DOCTOR'S OFFICE CONFIRMED THAT THERE WAS NO INDICATION OF LEADS NOT BEING IN THE PROPER PLACE. THE DEVICE IS STILL IN USE. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other (B)(4) IMPLANTABLE LEAD ADAPTOR| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD