BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 2952631 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00130
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 13, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EROSION AND NECROSIS OCCURRED. THE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57768 PROTECTA XT VR NIK IPG MFG SWITZERLAND D354VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R