BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3990439 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-14443
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    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
    OH, 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 AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT MEDICAL PRODUCTS: 7120 LEAD, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION DUE TO HIGH THRESHOLDS ON THE LEFT VENTRICULAR (LV) LEAD. LV CAPTURE WAS INTERMITTENT AT THE HIGHEST OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE DEVICE CHANGEOUT THE ORIGINAL INTENT WAS TO ATTEMPT TO REMOVE OR REPOSITION THE LV LEAD OR ADD AN ADDITIONAL LV LEAD. THE PATIENT¿S ANATOMY WOULD NOT ALLOW FOR ADDITIONAL LEADS TO BE PLACED BECAUSE THE SUBCLAVIAN WAS OCCLUDED. EXTRACTION WAS ABANDONED BECAUSE THE LEAD GOT HUNG UP IN THE SUPERIOR VENA CAVA (SVC). BECAUSE THE PATIENT WAS DEPENDENT, THE LV PORT WAS PLUGGED AND THE PATIENT WAS BROUGHT BACK AT A LATER TIME TO EXTRACT THE LEAD AND ADDED A NEW LV LEAD. DURING THE SUBSEQUENT PROCEDURE TO EXTRACT THE LEAD, THE LEAD BROKE IN HALF AND THE REMAINING PORTION WAS SNARED FROM BELOW USING FEMORAL ACCESS. THE LEAD WAS REMOVED AND REPLACED. DURING THE LV LEAD EXTRACTION, THE RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS REPOSITIONED AND 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
    464303 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 4196 LEAD, 5076 LEAD