BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 3160425 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10080
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    March 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4193 IMPLANTABLE PACING LEAD (B)(6) 2008; 5076 IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING AND CONTINUED EPISODES OF NOISE AND SENSING INTEGRITY COUNTS (SIC) HAD BEEN SEEN. IT WAS ALSO REPORTED THAT A LEAD FRACTURE WAS SUSPECTED AND A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS NOT DISPLAYING HISTOGRAM DATA; REVIEW OF THE DEVICE MEMORY SHOWED THAT DATA HAD BEEN CLEARED DURING THE PRIOR SESSION. THE RV LEAD WAS EXPLANTED AND REPLACED; THE DEVICE 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
    259333 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR 6947 IMPLANTABLE DEFIB LEAD