BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2791389 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14830
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BREAST CANCER AND RESULTED IN MOVING THE IMPLANTABLE CARDIODEFIBRILLATOR SYSTEM TO THE RIGHT SIDE OF THEIR BODY. DURING THE REPOSITIONING PROCEDURE THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO "POST SHOCK NOISE" DURING THE DEFIBRILLATION THRESHOLD TESTING IN THE RIGHT VENTRICULAR LEAD. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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 SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening