BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 3152668 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06725
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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). 6940 IMPLANTABLE TACHY LEAD 2000 (B)(6); 4543 COMPETITOR IMPLANTABLE PACING LEAD 2009 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD SHOWED A SHORT INTERVAL COUNT OF 28 AND THERE WERE EPISODES OF N ON-SUSTAINED TACHYCARDIA EPISODES WHERE THERE WAS OVERSENSING. THE IMPEDANCE WAS STABLE AND ISOMETRICS DID NOT PROVOKE OVERSENSING. THE LEAD INTEGRITY ALERT WAS LOADED ON THE DEVICE 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
    252262 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR