BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 2812063 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05981
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 12, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. EVALUATION SUMMARY: (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WITHHELD THERAPY UNTIL THE RHYTHM EXCEEDED THAN THE SUPRAVENTRICULAR TACHYCARDIA [SVT] LIMIT AND THEN AN APPROPRIATE SHOCK WAS DELIVERED. IT WAS ALSO REPORTED THAT BECAUSE THE DEVICE WITHHELD THERAPY, THE PATIENT PASSED OUT. THE PATIENT ALSO TOOK "LONGER THAN NORMAL TO COME AROUND" AFTER THE EVENT. THE PHYSICIAN BELIEVED THE PATIENT EXPERIENCED ENCEPHALOPATHY BECAUSE THE PATIENT'S "BRAIN WAS STRESSED." THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS "MENTALLY INTACT." NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD