BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2813278 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06476
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THAT THE DIAGNOSTICS PROBLEM WAS EXPECTED BEHAVIOR. IT WAS ALSO NOTED THAT A BIT FLIP IN A DIAGNOSTIC TREND DOES NOT DISPLAY EVIDENCE OF A BIT FLIP AS A POWER ON RESET (POR). THE ANALYST NOTED THAT THE BATTERY VOLTAGE WAS NOT AVAILABLE DUE TO A BIT FLIP IN THE LEAD IMPEDANCE/BATTERY VOLTAGE TRENDS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THAT THE DIAGNOSTICS PROBLEM WAS EXPECTED BEHAVIOR. IT WAS ALSO NOTED THAT A BIT FLIP IN A DIAGNOSTIC TREND DOES NOT DISPLAY EVIDENCE OF A BIT FLIP AS A POWER ON RESET (POR).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE AND THEN FIVE MONTHS LATER, THE DEVICE WAS NOT ABLE TO DISPLAY BATTERY VOLTAGE MEASUREMENTS AND THE TREND WAS SHOWN AS "INVALID." PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED; IT WAS DETERMINED THAT A BIT FLIP IN DEVICE MEMORY OCCURRED. THE BATTERY VOLTAGE MEASUREMENT DATA WAS RECONSTRUCTED AND IS AVAILABLE TO THE PHYSICIAN. 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
    1 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL, INC. RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other 5086MRI X2 IMPLANTABLE PACING LEADS