BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4161771 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11389
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 17, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. HOWEVER, THE DISTAL LV (LOW V OLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT AND BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. HELIX EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE PATIENT EXPERIENCED THE FIRST OF THREE EPISODES OF A SUDDEN ONSET OF CHEST DISCOMFORT AND SHORTNESS OF BREATH THAT SUBSIDED WITH REST. SEVERAL DAYS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH THE SYMPTOMS OF SHORTNESS OF BREATH AND CHEST PRESSURE ASSOCIATED WITH DIAPHORESIS AND THE PATIENT WAS HYPOTENSIVE. AN ECHOCARDIOGRAM SHOWED A PERICARDIAL EFFUSION AND TAMPONADE. A RIGHT VENTRICULAR (RV) LEAD PERFORATION WAS SUSPECTED. SINCE IMPLANT, THE LEAD IMPEDANCE WAS TRENDING DOWN AND THE THRESHOLD WAS CLIMBING. IT WAS ALSO NOTED THAT THE R WAVES WERE SLIGHTLY SMALLER THAN AT IMPLANT. THE PERICARDIAL EFFUSION WAS DRAINED AND THE LEAD WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE (B)(6) MRI STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639224 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization| L| R DDMB1D4 ICD, 5076-45 LEAD