BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2952863 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01817
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 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 PRODUCT: 4076 NON-DEFIB LEAD: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THROAT SURGERY. AFTER SURGERY, THE PHYSICIAN ATTEMPTED TO REPROGRAM THE DEVICE BACK ON AND NOTICED THAT SOME OF THE PARAMETERS WERE DIFFERENT, AND ALL OF THE ALERTS WERE PROGRAMMED OFF. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND THERE WAS NO SIGN OF AN ELECTRICAL RESET OR MEMORY ERROR. IT WAS DETERMINED THAT THE PHYSICIAN MUST HAVE INADVERTENTLY HIT "GET NOMINALS". THE DEVICE WAS REPROGRAMMED TO ORIGINAL SETTINGS AND ALERTS WERE TURNED ON. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THROAT SURGERY. AFTER SURGERY, THE PHYSICIAN ATTEMPTED TO REPROGRAM THE DEVICE BACK ON AND NOTICED THAT SOME OF THE PARAMETERS WERE DIFFERENT, AND ALL OF THE ALERTS WERE PROGRAMMED OFF. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND THERE WAS NO SIGN OF AN ELECTRICAL RESET OR MEMORY ERROR. IT WAS DETERMINED THAT THE PHYSICIAN MUST HAVE INADVERTENTLYHIT "GET NOMINALS". THE DEVICE WAS REPROGRAMMED TO ORIGINAL SETTINGS AND ALERTS WERE TURNED ON. THE DEVICE 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
    57118 ENTRUST AT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention 6949 DEFIB LEAD