BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 2955481 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02060
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 4, 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
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS: 0185 COMPETITOR IMPLANTABLE TACHY LEAD - (B)(6) 2006; 4470 COMPETITOR IMPLANTABLE PACING LEAD -(B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. NO ANOMALIES WERE FOUND.

    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 PATIENT RECEIVED AN UNNECESSARY SHOCK WHEN THE DEVICE ALGORITHM FAILED TO WITHOLD A SHOCK DUE TO T-WAVE OVERSENSING (TWOS). FOLLOW UP IS CURRENTLY IN PROCESS FOR ADDITIONAL INFORMATION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN UNNECESSARY SHOCK WHEN THE DEVICE ALGORITHM FAILED TO WITHOLD A SHOCK DUE TO T-WAVE OVERSENSING (TWOS). IT WAS FURTHER REPORTED THAT THE DEVICE SENSITIVITY WAS REPROGRAMMED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58593 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Life Threatening 4194 IMPLANTABLE PACING LEAD