BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 7582026 · Received June 8, 2018

    Report

    Report Number
    2649622-2018-09571
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    July 23, 2017
    Report Date
    June 8, 2018
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 419388 LEAD, IMPLANTED 2005-02-22; 456853 LEAD, IMPLANTED 2001-03-28 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE CLINIC INDICATED THAT THE PATIENT HAD FOLLOWED UP IN HOSPITAL AND INAPPROPRIATE SHOCK WAS ALSO NOTED WITH THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTION WAS DONE. THE LEAD REMAINS 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
    425190 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6943-65

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening D314TRG CRTD