BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM VR

    MDR report key: 6925113 · Received October 6, 2017

    Report

    Report Number
    2182208-2017-01731
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    January 11, 2005
    Report Date
    August 2, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: OUTCOME OF MAGNETIC RESONANCE IMAGING (MRI) IN SELECTED PATIENTS WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). PACE 2005; 28:270¿273.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) USE DURING MAGNETIC RESONANCE IMAGING (MRI). THE ARTICLE REPORTS ONE POWER ON RESET (POR) DURING AN MRI. IT WAS NOTED THE CAUSE OF THE POR WAS DUE TO "A MICROPROCESSOR INSTRUCTION ERROR AND/OR MEMORY ERROR". IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED UNWANTED PECTORAL MUSCLE STIMULATION PRIOR TO THE MRI AND RESET. THE STATUS OF THE DEVICE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700652 GEM VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 7227CX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention