BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 2965036 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02279
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 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
    AL, 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. (B)(4). CONCOMITANT PRODUCTS: 4194 IMPLANTABLE PACING LEAD (B)(6) 2004, 5554 IMPLANTABLE PACING LEAD (B)(6) 2004.

    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 ONE DAY POST IMPLANT OF A NEW DEVICE, AN INTERROGATION SHOWED HIGH ATRIAL LEAD IMPEDANCE AND THERE WAS A LEAD D ETECTION ALERT WITH OVERSENSING ON THE RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT DURING THE DEVICE CHANGE OUT, THE PHYSICIAN HAD TROUBLE BECAUSE OF THE LACK OF SLACK EXPOSED WITH THE CONNECTOR PINS. POSSIBLE SET SCREW ISSUES ON THE RA AND RV LEAD PINS WERE SUSPECTED. THE PATIENT UNDERWENT ANOTHER PROCEDURE TO CORRECT THE ISSUE AND 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
    69117 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD