BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC IPG

    MDR report key: 9716639 · Received February 17, 2020

    Report

    Report Number
    2182208-2020-00306
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    January 1, 2019
    Report Date
    February 17, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE OVERALL BASELINE GENDER CHARACTERISTICS IS MALE; THE AGE OF THE PATIENTS WAS 69 YEARS OLD. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS/MANUFACTURERS. POSSIBLE MODELS COULD INCLUDE: MAXIMO 2, KAPPA KSR401, KDR401, MICRA. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE:¿CLINICAL EXPERIENCE OF MAGNETIC RESONANCE IMAGING IN PATIENTS WITH CARDIAC PACING DEVICES: UNRESTRICTED PATIENT POPULATION.¿ ACTA RADIOLOGICA. 2019, VOL. 60(11) 1414¿1421. DOI: 10.1177/0284185119830288. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATORS (IPGS) UNDERGOING MAGNETIC RESONANCE IMAGING (MRI) EXAMINATIONS. THE AUTHOR INDICATED THAT THERE WERE PATIENTS WHO EXPERIENCED INFECTIONS, POWER ON RESETS (PORS), ¿NOISE¿ FROM THE DEVICE WHEN ENTERING THE MAGNETIC FIELD (OF NOTE, THIS PATIENT DID NOT UNDERGO THE MRI), AND DEVICE RESETS DUE TO ¿TEMPORARY¿ PROGRAMMED HIGH OUTPUT VOLTAGE. THE AUTHOR ALSO NOTED THAT THERE WAS "ONE POTENTIALLY DANGEROUS ADVERSE EVENT" WITH ONE OF THE DEVICES; THE DEVICE "FELL INTO THE ELECTIVE REPLACEMENT INDICATOR (ERI) MODE" FOR THE PACING-DEPENDENT PATIENT. NO ILL EFFECTS TO THE PATIENT WERE NOTED. THE DEVICES WERE REPLACED AND/OR REPROGRAMMED. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS/MANUFACTURERS. THE LOCATION OF THE DEVICE IS UNKNOWN; BUT APPEARS TO BE STILL IN USE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181062 MEDTRONIC IPG PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R