BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-P

    MDR report key: 4163361 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02459
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A LOOSE/DETACHED SET SCREW. PRODUCTS: 5076-52 LEAD IMPLANTED 2005 (B)(6); 4543 BOSTON SCIENTIFIC LEAD IMPLANTED 2005 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD INDICATED NOISE AND A POSSIBLE FRACTURE. DURING THE LEAD REVISION PROCEDURE, THE PHYSICIAN ATTEMPTED TO PUT THE LEFT VENTRICULAR (LV) LEAD INTO THE DEVICE'S RIGHT VENTRICULAR (RV) PORT. THE SETSCREW HAD BEEN UNSCREWED TOO FAR, HOWEVER, AND COULD NOT BE RE-ENGAGED. THE DEVICE WAS REMOVED AND REPLACED. THE RV LEAD WAS CAPPED AND REPLACED USING THE EXISTING LV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644127 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 6947-65 LEAD