BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3993483 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09282
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. CONCOMITANT PRODUCTS: DDBB1D1, ICD, IMPLANTED (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD AN ALERT AND ON INTERROGATION IT WAS NOTED THAT THERE WAS HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. FRACTURE WAS SUSPECTED, AND THE SUPERIOR VENA CAVA (SVC) COIL WAS TURNED OFF. DEFIBRILLATION THRESHOLD TESTING WAS ACCEPTABLE WITH THE SVC COIL TURNED OFF, HOWEVER THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468147 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694458

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R 5076 LEAD