BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992135 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10050
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2010
    Report Date
    May 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY PRESENTED TO THEIR PHYSICIAN'S OFFICE AFTER THEIR "DEVICE WENT OFF 32 TIMES". THE PATIENT UNDERSTOOD THAT THE RIGHT VENTRICULAR (RV) LEAD WAS "GROWN OVER", AND WAS SHOCKED 7 TIMES. THE PATIENT REPORTS GETTING SEVERAL SHOCKS EVERY NIGHT, JUST AS THEY ARE GOING OFF TO SLEEP. THE PATIENT STATES THAT ONE OCCURRENCE INCLUDED PRESSURE, WITH A FEELING OF BEING CRUSHED AND VERY HEAVY IN THEIR CHEST. THE PATIENT ALSO REPORTS THAT THEY FELT A SHOCK WHILE SHOPPING, UP IN THEIR PECTORAL MUSCLE, OF WHICH WAS MORE SEVERE. THE PATIENT HAS DISCUSSED THIS WITH THEIR PHYSICIAN AND UNDERSTOOD THAT THE DEVICE IS FUNCTIONING AS PROGRAMMED. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470441 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Life Threatening D284VRC ICD