BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 2954456 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02438
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. CONCOMITANT PRODUCTS: 4296 IMPLANTABLE PACING LEAD - (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO THE RIGHT VENTRICULAR (RV) LEAD HAVING OVERSENSING FROM A LOOSE CONNECTION. DURING THE REVISION PROCEDURE, THE RV LEAD WAS FOUND TO BE PARTIALLY INSERTED. THE RV LEAD WAS RE-INSERTED AND THE SET SCREW WAS TIGHTENED. THE RV LEAD AND DEVICE WERE PERFORMING AS EXPECTED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58273 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| L| R 6935M IMPLANTABLE TACHY LEAD