BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991136 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08302
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCT: D334DRG ICD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD. NOISE WAS OBSERVED ON STORED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES, AND THERE WERE HIGH IMPEDANCE MEASUREMENTS. FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED 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
    472062 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R 5076 LEAD