BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4160176 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12001
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY:THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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. CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS LATER REMOVED AS PART OF A COMPLETE SYSTEM EXTRACTION.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO SEIZURE-LIKE ACTIVITY. IT WAS THEN DISCOVERED THAT BOTH HIGH VOLTAGE PORTIONS OF THE RIGHT VENTRICULAR (RV) LEAD WERE EXHIBITING HIGH IMPEDANCE DUE TO SUSPECTED FRACTURE. THE PATIENT WAS SENT HOME WITH A LIFE VEST AND LATER RETURNED DUE TO CHEST DISCOMFORT. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637688 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Hospitalization| R D154AWG ICD