BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1854708 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09347
    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
    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 A PATIENT FELL AND BROKE A SHOULDER RESULTING IN SWELLING AROUND THE PATIENT'S IMPLANTABLE DEFIBRILLATOR (ICD). IT WAS FURTHER REPORTED THAT THE HIGH VOLTAGE LEAD IMPEDANCE DECREASED FROM 53 TO 35 OHMS AND THE PACING IMPEDANCE TO DECREASED FROM 700 TO 550 FOLLOWING THE PATIENT'S INJURY AND SUBSEQUENT HOSPITALIZATION. THE SYSTEM 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 63 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB