BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153746 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06205
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4076 IMPLANTABLE PACING LEAD, (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE THAT RESULTED IN HOSPITALIZATION DUE TO ORTHOPEDIC INJURIES. THE CAUSE IS UNKNOWN. AT INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD R WAVE AMPLITUDE SENSING HAD DECREASED IN THE LAST THREE MONTHS. NO UNDERSENSING WAS SEEN WITH TELEMETRY. R WAVE TESTING IN BIPOLAR AND INTEGRATED BIPOLAR VECTORS SHOWED POOR SENSING. THE SENSITIVITY WAS ADJUSTED. THE PATIENT WAS SEEN SUBSEQUENTLY AND THE R WAVE SENSING HAD IMPROVED TO A MORE STABLE AMPLITUDE. THE PHYSICIAN BELIEVES THE POOR SENSING WAS DIRECTLY CORRELATED TO A CHANGE IN THE CONDUCTION STATUS THAT HAS BEEN ADDRESSED MEDICALLY. THE LEAD REMAINS IN USE WITH CONTINUED MONITORING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255076 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| L| R D224DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR