BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951725 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00207
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 4, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. PRODUCT: 4194 IMPLANTABLE PACING LEAD (B)(6) 2007; 5076 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4)...

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING NOTED IN A STORED EPISODE. THE CLINICIAN PERFORMED ISOMETRICS, TWISTING, TURNING ETC. IN OFFICE AND THEY COULD NOT ELICIT ANY OVERSENSING. 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
    56572 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR