BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT RV

    MDR report key: 3061144 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05073
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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. (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN INCREASE IN IMPEDANCE AND WAS HIGH THEN RETURNED TO BASELINE. THE LEAD REMAINS IN USE AND WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163420 SPRINT RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR