BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2965120 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02385
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 20, 2012
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  WAS RETURNED AND ANALYZED. THERE WE NO ANOMALIES FOUND. CONCOMITANT PRODUCTS: 4194 IMPLANTABLE PACING LEAD (B)(6) 2012; 0293 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2012.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UPGRADE PROCEDURE, NOISE WAS HEARD WHEN THE HIGH VOLTAGE LEAD WAS INSERTED INTO THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). HOWEVER, THE WAS A CLEAN SIGNAL WHEN THE LEAD WAS TESTED ON THE ANALYZER. THE ICD WAS NOT USED AND A DIFFERENT ICD WAS IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68012 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR 5076 IMPLANTABLE PACING LEAD