BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC LEAD

    MDR report key: 7418275 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00586
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    January 29, 2016
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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. REFERENCED ARTICLE: ¿ELECTROMAGNETIC INTERFERENCE IN IMPLANTABLE CARDIOVERTER DEFIBRILLATORS: PRESENT BUT RARE.¿CLIN RES CARDIOL (2016) 105:657¿665. DOI 10.1007/S00392-016-0965-1. 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 CARDIOVERTER DEFIBRILLATORS (ICDS) SYSTEMS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENTS WHO EXPERIENCED INAPPROPRIATE SHOCKS. THERE WAS REPORTED ELECTROMAGNETIC INTERFERENCE (EMI) FROM THE FOLLOWING SOURCES: LAWN MOWER, MOBILE PHONE, WET PAINT ON WALL/OUTLET, UNGROUNDED CURRENT GENERATOR, LAPTOP COMPUTER, ¿NOT DETERMINABLE,¿ AND ELECTROCAUTERY DURING CARDIAC SURGERY. THERE WERE MODE SWITCHES, AND OVERSENSING NOTED. THE TREATMENT/INTERVENTION/RESOLUTION IS UNKNOWN AT THE TIME OF THIS REPORT. 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
    258477 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R