BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3990766 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14400
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT THE TIME IS APPROACHING FOR DEVICE REPLACEMENT. CONCOMITANT PRODUCTS: (B)(4) LEAD, IMPLANTED 2011 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RECEIVED AND ANALYZED. THE RETURNED DEVICE INDICATED LOCK-UP IN AN INTEGRATED CIRCUIT. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT THE TIME IS APPROACHING FOR DEVICE REPLACEMENT. NOTCH BATTERY VOLTAGE TREND WAS OBSERVED AND ERI WAS NOTED TO BE TRIGGERED ON (B)(6) 2015.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR (IPG) HAS REACHED END OF SERVICE (EOS). DEVICE HAS BEEN REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE HAS UNEXPECTED LONGEVITY BUT HAD NOT REACHED ELECTIVE REPLACEMENT INDICATOR. 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
    469814 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR (B)(4) LEAD