BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSURA DR MRI SURESCAN

    MDR report key: 2955141 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00214
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    March 27, 2012
    Report Date
    November 19, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA FROM THE DEVICE WAS REVIEWED AND REVEALED THAT THE DEVICE EXPERIENCED A PARTIAL ELECTRICAL RESET, WITH A "SINGLE BIT ECC-ERROR" ON (B)(4) 2012 AND "SINGLE BIT TOTAL PARITY ECC-ERROR" ON (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP, IT WAS DETERMINED THAT THERE HAD BEEN BIT FLIP IN THE DEVICE MEMORY. THE PATIENT WAS PLANNING TO RETURN TO THE HOSPITAL TO HAVE THE INVALID MEMORY ERASED. THE PHYSICIAN WAS GOING TO ASK THE PATIENT IF THEY HAD UNDERWENT RADIATION THERAPY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP, IT WAS DETERMINED THAT THERE HAD BEEN BIT FLIP IN THE DEVICE MEMORY. THE PATIENT WAS PLANNING TO RETURN TO THE HOSPITAL TO HAVE THE INVALID MEMORY ERASED. THE PHYSICIAN WAS GOING TO ASK THE PATIENT IF THEY HAD UNDERWENT RADIATION THERAPY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP, IT WAS DETERMINED THAT THERE HAD BEEN BIT FLIP IN THE DEVICE MEMORY. THE PATIENT WAS PLANNING TO RETURN TO THE HOSPITAL TO HAVE THE INVALID MEMORY ERASED. THE PHYSICIAN WAS GOING TO ASK THE PATIENT IF THEY HAD UNDERWENT RADIATION THERAPY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59121 ENSURA DR MRI SURESCAN LWP IPG MFG SWITZERLAND EN1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention