BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 2964833 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02321
    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
    FL, 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 AN ANALYSIS FOUND NO ANOMALIES. (B)(4). CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2006; 6949 IMPLANTABLE TACHY LEAD (B)(6) 2006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE A DEVICE CHANGE OUT THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE HAD BEEN HIGH AND TRIGGERED A PATIENT ALERT. AT THE REVISION PROCEDURE, IT WAS NOTED THAT THE LEAD PIN HAD PULLED BACK AND WAS NOT COMPLETELY IN THE DEVICE HEADER. THE LEAD WAS REATTACHED BUT THE HIGH IMPEDANCE REMAINED. A DEVICE HEADER/GROMMET ISSUE WAS SUSPECTED. THE PATIENT REPORTED THAT THE PHYSICIAN COMMENTED DURING THE CASE THAT THE DEVICE SET SCREW WAS NOT MAKING PROPER CONTACT BECAUSE IT WASN'T DRILLED IN FAR ENOUGH. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69112 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 00069 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD