BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2952531 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01750
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCT: 5086MRI IMPLANTABLE PACING LEAD, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT "PACEMAKER IS KICKING IN" WHEN THE PATIENT DRIVES THE GOLF CART. FOLLOW UP CONFIRMED THE HEALTH PROFESSIONAL HAS SEEN THE PATIENT ON MULTIPLE DATES BUT THE PATIENT CONTINUES TO FEEL WOOZY (DEVICE KICKING) ONLY WHEN THE PATIENT IS RIDING THE GOLF CART. THE HEALTH PROFESSIONAL ADVISED THE PATIENT TO PLACE SOME SORT OF METAL PLATE OVER THE BATTERY COMPARTMENT OF THE GOLF CART, AS THE HEALTH PROFESSIONAL BELIEVES THERE IS ELECTRICAL INTERFERENCE TAKING PLACE. 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
    56507 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 5086MRI IMPLANTABLE PACING LEAD