BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT VR

    MDR report key: 2890228 · Received December 28, 2012

    Report

    Report Number
    9614453-2012-00390
    Event Type
    Death
    Date Received
    December 28, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 7, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION ABOUT THE EVENT HAS BEEN REQUESTED AND NOT MADE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED LESS THAN ONE YEAR AFTER THE IMPLANT. FOLLOW UP INFORMATION HAS BEEN REQUESTED AND NOT MADE AVAILABLE. NO SPECIFIC COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM OR ANY OF THE SPECIFIC COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D314VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death