BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3991180 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08254
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    December 8, 2025
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCT: 407645 LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TRIGGERED, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/VARYING IMPEDANCES. THE PATIENT LATER RECEIVED FOUR INAPPROPRIATE THERAPIES DUE TO OVERSENSING. THE DEFIBRILLATION PORTION OF THE LEAD WAS PROGRAMMED OFF, AND THE PATIENT WAS DOWNGRADED FROM A DEFIBRILLATOR TO A PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472323 SPRINT QUATTRO SECURE S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Life Threatening| H| R D224DRG ICD