BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153410 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05986
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4).

    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 - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE TWO VENTRICULAR FIBRILLATION EPISODES EQUAL TO 200 MILLISECONDS AVERAGE PER VENTRICULAR CYCLE ON 2012-12-03. THE VENTRICULAR SHORT INTERVAL IS EQUAL TO 1150 COUNTS IN 21.83 DAYS, BETWEEN (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SUTURE HOLD CAME LOOSE AND THE DEVICE FLIPPED IN THE POCKET PULLING THE RIGHT VENTRICULAR LEAD INTO THE SUPERIOR VENA CAVA. 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
    256495 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R D334VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR