BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153239 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05901
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 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. PRODUCT: 5076-52 IMPLANTABLE PACING LEAD (B)(6) 2013 ; D314DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED PLEURAL EFFUSION TWO TO THREE WEEKS POST IMPLANTATION. THE PHYSICIAN QUESTIONED IF THERE WAS PERFORATION BUT WAS UNABLE TO VERIFY ON X-RAY, ECHO, OR CT (COMPUTED TOMOGRAPHY). THEREFORE BOTH, THE ATRIAL AND RIGHT VENTRICULAR LEADS, WERE REPOSITIONED AND REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256084 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Hospitalization| L| R