BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951638 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00166
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 2, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 4076, IMPLANTABLE PACING LEAD, (B)(6) 2008; 6935, IMPLANTABLE TACHY LEAD, (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT FOR THE LEAD'S OUT OF RANGE SUPERIOR VENA CAVA (SVC) IMPEDANCE. THE RIGHT VENTRICULAR (RV) AND SVC IMPEDANCES BOTH SHOWED VARIABILITY AND THE CURRENT RV TIP TO RV COIL SHOWED NOISE ON THE ELECTROGRAM. FURTHER TESTING WAS RECOMMENDED AND 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
    55902 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR