BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2955089 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00820
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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. CONCOMITANT PRODUCT: 1688TC COMPETITOR IMPLANTABLE PACING LEAD: (B)(6) 2010. A 4194 IMPLANTABLE PACING LEAD: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION EPISODES THAT THE DEVICE HAD NOISE ON THE ATRIAL CHANNEL AND IT WAS OVERSENSED. THERE ALSO APPEARED TO BE SOME NOISE ON THE BASELINE FOR THE RIGHT VENTRICULAR (RV) LEAD CHANNEL BUT IT WAS NOT SENSED AND THE VENTRICULAR RHYTHM WAS PACED DURING THE EPISODES. THE DEVICE AND RV LEAD REMAIN 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
    58609 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR