BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2952358 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01704
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    August 17, 2012
    Report Date
    January 11, 2024
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    UDI-DI
    00613994614742
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF UNFROZEN STRIP WITH SURFACE ELECTROCARDIOGRAM SHOWS DROPPED BEAT DURING EVENT, LIKELY DUE TO TELEMETRY DROP-OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC FOR A DEVICE CHECK AND WHILE RESTING WITH THE PROGRAMMING HEAD ON, THERE WAS A LOSS OF TELEMETRY FOR ONE BEAT AS SEEN ON THE ELECTROGRAM. THE DEVICE IS STILL IN USE. THE CLINICIAN WILL CONTINUE TO MONITOR THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57381 REVO MRI SURESCAN IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01 00613994614742

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Male 5086MRI IMPLANTABLE PACING LEADS X 2