BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2953506 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01126
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT CONTINUED: (B)(4), IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    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 THE PATIENT RECEIVED MULTIPLE SHOCKS AND WAS TAKEN BY AMBULANCE TO THE HOSPITAL. THE LEAD REMAINS IN USE. NOFURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT RECEIVED MULTIPLE SHOCKS AND WAS TAKEN BY AMBULANCE TO THE HOSPITAL. FOLLOW-UP INFORMATION RECEIVED FROM THE CLINIC DISCLOSED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM BECAUSE OF AN ELECTRICAL STORM AS A RESULT OF THE PATIENT'S HEART MEDICATION. THE CLINIC CONFIRMED THE DEVICE FUNCTION WAS NORMAL. THE PATIENT'S MEDICATION WAS CHANGED AND THE DOSAGE ADJUSTED. 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
    56335 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR