BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3152898 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08861
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD - 2001 (B)(6); 4592 COMPETITOR IMPLANTABLE PACING LEAD - 2010 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED POSSIBLE EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE NEW DEVICE WAS CONNECTED TO THE EXISTING RIGHT VENTRICULAR (RV) LEAD, AND WOULD NOT PACE. THE DEVICE WAS DISCONNECTED, AND THEN CONNECTED TO THE EXISTING ATRIAL LEAD, WITH THE SAME RESULTS. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED POSSIBLE EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE REPL ACEMENT PROCEDURE, THE NEW DEVICE WAS CONNECTED TO THE EXISTING RIGHT VENTRICULAR (RV) LEAD, AND WOULD NOT PACE. THE DEVICE WAS DISCONNECTED, AND THEN CONNECTED TO THE EXISTING ATRIAL LEAD, WITH THE SAME RESULTS. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257854 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 00087 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD