BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 1791822 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03056
    Event Type
    Injury
    Date Received
    August 10, 2010
    Report Date
    June 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE FELT A SHOCKING SENSATION AND THAT THE THOUGHT THE DEVICE WAS "OFF". SHE HAS SEEN HER DOCTORS AND GOTTEN OTHER OPINIONS, AND WAS TOLD THE "DEVICE WAS WORKING" BY SOME, AND "DEVICE WAS WORKING BUT NOT WORKING FOR YOU" BY OTHERS. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE STARTED TO PASS OUT, AND ASKED "ARE MY DEVICES WORKING AND WHY AM I PASSING OUT?" THE PATIENT FURTHER REPORTED THAT OVER THE PAST YEAR SHE PASSED OUT FOUR TIMES AND HAD DIZZINESS, WITH BLOOD PRESSURE OVER 200. THE PATIENT WONDERED IF THE DEVICE WAS CAUSING HER TO FAINT. THE PATIENT ALSO REPORTED THAT SHE WAS QUESTIONING THE MANUFACTURING DATE OF THE CRT-P DEVICE AND THAT SHE HAS HAD "PROBLEMS" WITH IT, INCLUDING "HURTING" AND PASSING OUT AND FEELING DIZZY. THE PATIENT FURTHER REPORTED THAT SHE FELT A SHOCKING SENSATION AND THAT THE THOUGHT THE DEVICE WAS "OFF". SHE HAS SEEN HER DOCTORS AND GOTTEN OTHER OPINIONS, AND WAS TOLD THE "DEVICE WAS WORKING" BY SOME, AND "DEVICE WAS WORKING BUT NOT WORKING FOR YOU" BY OTHERS. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT FURTHER REPORTED THAT THE DEVICE WAS SHOCKING THE PATIENT ALL THE TIME, AND THAT IT WAS TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| O 8040 IMPLANTABLE PULSE GENERATOR| 4092 IMPLANTABLE PACING LEAD| 4568 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5071 IMPLANTABLE PACING LEAD