BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1854975 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09184
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 A DEFIBRILLATION LEAD HAD A HIGH IMPEDANCE OBSERVED VIA REMOTE MONITORING; LATER, THE ASSOCIATED IMPLANTED DEFIBRILLATOR (ICD) WAS REPLACED AND AN ADDITIONAL PACING LEAD WAS PLACED IN THE RIGHT VENTRICLE; THE DEFIBRILLATION LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO 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 82 YR Other 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD