BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3990722 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08503
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR DAYS POST IMPLANT THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE FOUND TO BE DISLODGED ON X-RAY. THERE WAS NOISE ON THE RV ELECTROGRAM, RV SIGNALS WERE OBSERVED ON THE RA ELECTROGRAM, AND THE RV LEAD DID NOT CAPTURE AT HIGH OUTPUT. THE RA LEAD EXHIBITED HIGH/UNSTABLE THRESHOLDS AND OVERSENSING/NOISE. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE, AND THE RA 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
    472155 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R DTBB1D4 ICD, 4196 LEAD, 4076 LEAD