BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2955473 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02062
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 17, 2012
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.(B)(6) CONCOMITANT PRODUCTS CONTINUED: SP02 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 1998. (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. ANALYSIS REVEALED THAT THE DEVICE HAD A FULL ELECTRICAL RESET. THERE WAS A CRITICAL RAM PARITY ERROR ON (B)(4) 2012 AND MEM TEST POWER ON RESET (POR) ON (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME IN FOR A DEVICE CHECK SINCE THEIR DEVICE HAS BEEN BEEPING. IT WAS FOUND THAT THE DEVICE HAD AN ELECTRICAL RESET DUE TO THE PATIENT GOING THROUGH RADIATION THERAPY. THE RESET WAS CLEARED. IT WAS FURTHER REPORTED THAT A SECOND ELECTRICAL RESET HAD OCCURRED AS THE PATIENT IS IN THE MIDDLE OF A LONG COURSE OF RADIATION THERAPY AND THE CALLER WAS WONDERING IF THIS CAN BE PREVENTED. RADIATION GUIDELINES WERE SENT TO THE CLINIC AND 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
    59557 ENTRUST VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR V194 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB