BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3993354 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14640
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4).

    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: D314TRG DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT PRODUCT: 419588 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED BY THE PATIENT THAT THE ¿BATTERY WAS IN PIECES.¿ THE PATIENT ALSO REPORTED THAT A FEW YEARS AGO, THE DEVICE WAS ¿UNHOOKED¿ AND WHEN IT WAS ¿HOOKED UP¿ IT FELT LIKE A ¿BABY KICKING IN THERE.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLY AND THE DEVICE ONLY LASTED 2 YEARS DUE TO HIGH OUTPUTS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE DUE TO A LEAD FRACTURE. THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD WAS CAPPED 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
    468853 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 00074 YR Hospitalization| R 6949 LEAD