BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 4161742 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19019
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    April 10, 2014
    Report Date
    August 12, 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
    SC, 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. THE DEVICE MET 84% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INDICATED END OF SERVICE (EOS) AND HAD UNEXPECTED BATTERY LONGEVITY; IT LASTED 2.5 YEARS. IT WAS ALSO NOTED THAT THE PATIENT HAD LOW HEMOGLOBIN (HGB) DURING THE REPLACEMENT PROCEDURE AND WAS ADMITTED FOR A BLOOD TRANSFUSION. THE DEVICE WAS EXPLANTED 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
    640709 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 1258T LEAD, 6947M-62 LEAD