BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992133 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10051
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PRODUCTS: 5076-52 LEAD IMPLANTED 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RECEIVED A SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHILE THEY WERE SLEEPING AND REPORTED TO THE EMERGENCY ROOM FOR EVALUATION. INTERROGATION OF THE DEVICE REVEALED THAT AN ELECTRICAL RESET HAD OCCURRED AT THE TIME OF THE SHOCK AND THAT THE SHOCK WAS DELIVERED WITHOUT QUALIFYING SYMPTOMS. IT WAS ALSO DETERMINED THAT THE DEVICE HAD LOST TELEMETRY FUNCTION PERMANENTLY. THE PATIENT REPORTED FEELING ANXIOUS FROM THE SHOCK AND WAS ADMITTED TO THE HOSPITAL. THE DEVICE WAS LATER EXPLANTED AND REPLACED AS PART OF AN UPGRADE PROCEDURE. THE ASSOCIATED RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS 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
    471440 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Hospitalization| L| R (B)(4) DEVICE