BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2790842 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03261
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 1, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    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. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. NO ANOMALIES WERE FOUND IN THE ANALYSIS OF THE DATA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF DIZZINESS. THE ELECTROCARDIOGRAM (EKG) REVEALED A PAUSE AND THAT THE PACED HEART RATE WAS LOWER THAN THE LOWER PROGRAMMED RATE. IT WAS FURTHER NOTED THAT THE DEVICE INTERROGATION SHOWED T-WAVE OVERSENSING IN THE RIGHT VENTRICULAR LEAD CAUSING THE RATE TO FALL BELOW THE PROGRAMMED LOWER PACING RATE. THE LEAD SENSITIVITY WAS REPROGRAMMED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB