BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT VR

    MDR report key: 2952464 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00118
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 27, 2012
    Report Date
    February 15, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016/S218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. IT WAS NOT POSSIBLE TO CONFIRM THE PRODUCT PROBLEM THROUGH ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT, THE DEVICE WAS BEING TESTED AND EXHIBITED A LONG CHARGE TIME. THE DEVICE WAS NOT USED AND WAS NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT, THE DEVICE WAS BEING TESTED AND EXHIBITED A LONG CHARGE TIME. THE DEVICE WAS NOT USED AND WAS NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57809 PROTECTA XT VR LWS IPG MFG SWITZERLAND D354VRM

    Patients

    Seq Age Sex Outcome Treatment
    1