BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT VR

    MDR report key: 3152838 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01096
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    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. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE DEVICE WAS REMOVED FROM THE PACKAGE, AND AN IMPURENESS WAS NOTED ON THE DEVICE SURFACE. IT WAS INITIALLY SUSPECTED TO BE A SCRATCH, HOWEVER, AFTER RUBBING THE AREA OVER THE SUSPECTED SCRATCH, A FLAKE OF WHAT APPEARED TO BE EITHER GLUE OR SILICONE CAME OFF. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE DEVICE WAS REMOVED FROM THE PACKAGE, AND AN IMPURENESS WAS NOTED ON THE DEVICE SURFACE. IT WAS INITIALLY SUSPECTED TO BE A SCRATCH, HOWEVER, AFTER RUBBING THE AREA OVER THE SUSPECTED SCRATCH, A FLAKE OF WHAT APPEARED TO BE EITHER GLUE OR SILICONE CAME OFF. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257651 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354VRG

    Patients

    Seq Age Sex Outcome Treatment
    1