BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 3863092 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01311
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    July 31, 2012
    Report Date
    July 3, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATI ENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME BRAND FAMILY AS A DEVICE MARKETED IN THE U.S. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE DEVICE POCKET AND WAS TREATED WITH ANTIBIOTICS AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS PLANNED TO BE REPLACED. THE PATIENT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339814 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 6944-65 IMPLANTABLE TACHY LEAD