BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 7099405 · Received December 8, 2017

    Report

    Report Number
    2182208-2017-02165
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    January 1, 2017
    Report Date
    December 8, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 63 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. 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: ¿MAGNETIC RESONANCE IMAGING IN PATIENTS WITH CARDIAC IMPLANTED ELECTRONIC DEVICES: FOCUS ON CONTRAINDICATIONS TO MAGNETIC RESONANCE IMAGING PROTOCOLS.¿ EUROPACE (2017) 19, 812¿817. DOI:10.1093/EUROPACE/EUW122. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATOR (IPG) SYSTEMS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS WITH THE AVAILABLE INFORMATION PROVIDED. THE AUTHOR REPORTED THERE WAS ONE (1) PATIENT WITH ¿RECURRENT¿ SEIZURES WHO HAD A FRACTURED LEAD WHICH WAS FOUND ONE MONTH AFTER THE MAGNETIC RESONANCE IMAGING (MRI) WAS COMPLETED. THERE WERE NO CHANGES IN SENSING AND CAPTURE THRESHOLDS RIGHT AFTER THE MRI AND ONE WEEK POST-MRI. THE STATUS/LOCATION OF THE IPG SYSTEM IS UNKNOWN. 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
    878902 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other IMPLANTABLE PULSE GENERATOR (IPG)