BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993606 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09230
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 8, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT MEDICAL PRODUCTS: 419488 LEAD, IMPLANTED (B)(6) 2010; 407645 LEAD, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE INTERROGATED WHILE IN THE HOSPITAL FOR AN UNRELATED EVENT. STORED DEVICE DATA REVEALED THAT A CARE ALERT HAD OCCURRED ABOUT A MONTH PRIOR DUE TO A HIGH IMPEDANCE READING ON THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. THE FOLLOWING DAY THE SVC IMPEDANCE WAS RECORDED TO BE LOWER AND THEN SUBSEQUENTLY RETURNED BACK TO NORMAL, BASELINE VALUES WHERE IT REMAINED. THE IMPEDANCE ON THE RV DEFIBRILLATION PORTION OF THE LEAD HAD REMAINED STABLE THROUGHOUT. IT WAS NOTED THAT THE PATIENT HAD NOT HAD A RECENT FOLLOW UP AND DID NOT HAVE A PHYSICIAN WHO FOLLOWED HIS DEVICE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468337 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR D224TRK DEVICE