BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2964628 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02280
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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

    WE ARE REDACTING THIS REPORT BECAUSE NO PRODUCT PROBLEM OR ADVERSE EVENT WAS REPORTED TO MEDTRONIC AS A RESULT OF THE MRI SCAN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INADVERTENTLY UNDERWENT AN MRI (MAGNETIC RESONANCE IMAGING) PROCEDURE. THERE WERE NO REPORTED PERFORMANCE ISSUES OR ADVERSE EVENTS AS A RESULT OF THE PROCEDURE. 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 THE PATIENT INADVERTENTLY UNDERWENT AN MRI (MAGNETIC RESONANCE IMAGING) PROCEDURE. A DEVICE INTERROGATION THE NEXT DAY SHOWED NO HISTORICAL DATA. 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
    67245 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR 5076 X2 IMPLANTABLE PACING LEADS