BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-P

    MDR report key: 3860746 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01157
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    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. CONCOMITANT MEDICAL PRODUCTS: A 693558 LEAD IMPLANTED: (B)(6) 2014. A 439678 LEAD IMPLANTED: (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG), THE LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED TRUE BIPOLAR, BUT WOULD NOT PACE UNTIL THE RIGHT VENTRICULAR (RV) LEAD WAS PUT INTO THE HEADER DUE TO IMPLANT DETECTION NEEDING TO COMPLETE. 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
    337189 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR 5076-45 LEAD