BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1717594 · Received June 10, 2010

    Report

    Report Number
    2649622-2010-06034
    Event Type
    Injury
    Date Received
    June 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. EVALUATION SUMMARY: (B) (4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA FROM THE ICD DEVICE SHOWED THE RV PACE IMPEDANCE WAS IN THE 800 - 900 OHM RANGE UNTIL THE WEEK ENDING (B) (6) 2010 WHEN THE VALUES BEGAN TO INCREASE REACHING A MIN/MAX OF 1408/1920 OHMS THE WEEK ENDING (B) (6) 2010. THE LEAD INTEGRITY ALERT WAS TRIGGERED ON (B) (6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERFORMANCE DATA FROM THE ICD DEVICE SHOWED IMPEDANCE ON RV PACING LEAD WAS STABLE IN LOW TO MID 900 OHM RANGE SINCE IMPLANT IN 2007. THE IMPEDANCE BEGAN TO INCREASE AT A RATE OF 35-100 OHMS/DAY STARTING (B) (6)-2010. IT WAS ALSO REPORTED THE IMPEDANCE HAD RISEN TO 1700 OHMS. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention (B) (4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4574 IMPLANTABLE PACING LEAD