BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153707 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06175
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMANCE AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LARGE SCAB AT THE HEADER OF THE DEVICE AND THERE WAS SWELLING AT THE DEVICE SITE. THE SCAB WAS EXCISED AND THE SKIN WAS FOUND INTACT UNDER THE SCAB, BUT AN OLD HEMATOMA WAS NOTED WHICH QUESTIONED A POSSIBLE INFECTION. THE DEVICE AND LEAD WERE EXPLANTED. THE POCKET WAS EXCISED AND CLOSED WITH A DRAIN IN PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254510 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R