BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-P

    MDR report key: 3062161 · Received April 16, 2013

    Report

    Report Number
    9614453-2013-00999
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    February 26, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH 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. 4296 IMPLANTABLE PACING LEAD 2012 (B)(6); 5076 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD WHICH WAS RESOLVED BY CHANGING THE LV PACING CONFIGURATION. ALSO, THE DEVICE WHICH HAD ONLY BEEN IMPLANTED APPROXIMATELY TWO AND A HALF MONTHS WAS INDICATING DEVICE LONGEVITY OF TWO YEARS. THE LV LEAD AND DEVICE BOTH REMAIN 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
    162963 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention