BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2813456 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16754
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. IMPEDANCE/HIGH IMPEDANCE: 2 - PATIENT ALERTS FOR HVB-HVA LEAD Z > 200 OHMS (B)(6) 2012 03:00:03 TO (B)(6) 2012 03:00:04. WEEKLY HV IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE FOR MIN AND MAX SVC = 49 TO 16382 OHMS PEAK BETWEEN (B)(6) 2012; 3 - PATIENT ALERTS FOR SVC(HVX) LEAD Z > 200 OHMS (B)(6) 2012 03:00:03 TO (B)(6) 2012 03:00:04. WEEKLY HV IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE FOR MIN AND MAX SVC = 61 TO 16382 OHMS PEAK BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH VOLTAGE AND PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WERE CAPPED DUE TO HIGH IMPEDANCESTHAT TRIGGERED A PATIENT ALERT. A NEW LEAD WAS IMPLANTED AND THE SUPRA VENA CAVA (SVC) PORTION OF THE EXISTING LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH VOLTAGE AND PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WERE CAPPED DUE TO HIGH IMPEDANCES THAT TRIGGERED A PATIENT ALERT. A NEW LEAD WAS IMPLANTED AND THE SUPRA VENA CAVA (SVC) PORTION OF THE EXISTING LEAD REMAINS IN USE. 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB