BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 3152335 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06863
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACING IMPEDANCE BEGAN FLUCTUATING UP INTO THE HIGH RANGE. A COMPETITIVE REPRESENTATIVE WAS ABLE TO REPRODUCE NOISE WITH ISOMETRICS. 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
    252853 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6942-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR UNK COMPETITOR ICD