BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1921268 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12425
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED HIGH RESISTANCE/IMPEDANCE. DAILY HIGH VOLTAGE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT CHANGE IN SUPERIOR VENA CAVA DEFIB IMPEDANCE FROM 57 TO 254 OHMS BETWEEN (B)(6)2010. IT WAS ALSO NOTED THAT THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6)2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HIGH VOLTAGE IMPEDANCE ON THE SUPERIOR VENA CAVA ELECTRODE HAD INCREASED, OVER A SHORT TIME, TO HIGH IMPEDANCE VALUES. IT WAS ALSO REPORTED THAT THERE WAS NOISE ON THE LEAD ELECTROGRAM. THE LEAD IS STILL IN USE, BUT IT WAS REPORTED THAT THE PATIENT MAY HAVE A LEAD REVISION AND A PATIENT ALERT WAS PROGRAMMED OFF. NO PATIENT COMPLICATIONS WERE 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 58 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB