BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 2953084 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00187
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 29, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PRODUCTS: 5068 IMPLANTABLE PACING LEAD, (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POST-OPERATIVE CHECK IT WAS NOTED THAT NO DIAGNOSTICS WERE RECORDED ON THE DEVICE. THE ATRIAL PORT WAS PLUGGED AND THE DEVICE PROGRAMMED VVIR. IMPLANT DETECT HAD NOT BEEN COMPLETED, SO THIS WAS PERFORMED MANUALLY. 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
    56191 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention 4193 IMPLANTABLE PACING LEAD