BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2813163 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06575
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S178
    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. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012. PROGRAMMER S2D DATA FILE (B)(4) SHOWS ONE ALERT EVENT FOR "A BIPOLAR LEAD IMPEDANCE 76 OHMS", 1- ALERT EVENT FOR "RV BIPOLAR LEAD IMPEDANCE 19 OHMS" AND 1- ALERT EVENT FOR "LVTIP TO RVCOIL LEAD IMPEDANCE 19 OHMS"ON (B)(4) 2012. ONE VENTRICULAR NST=193 MS ON (B)(4) 2012. ONE VF=190 MS AVERAGE V-CYCLE ON (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED THE DEVICE INTEGRATED CIRCUIT HAD GAT OXIDE/CAP OXIDE CURRENT LEAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A MALFUNCTION. THE DEVICE WAS EXPLANTED AND WAS REPLACED WITH A NEW DEVICE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR, RIGHT ATRIAL, AND LEFT VENTRICULAR LEADS HAD A SHARP DECREASE IN PACING IMPEDANCE. THERE WAS A LACK OF SENSING ON ALL THE LEADS. ALL THREE LEADS 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
    1 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL, INC. D314TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R