BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 6919870 · Received October 6, 2017

    Report

    Report Number
    2182208-2017-01486
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    January 1, 2015
    Report Date
    February 8, 2018
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE MODEL LISTED IN THE PLI IS A REPRESENTATIVE, AS THERE IS NO SPECIFIC MODEL LISTED WITH SPECIFIC DETAILS/COMPLAINTS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 69 YEARS OLD. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿ELECTRICAL PERFORMANCE AND LEAD HANDLING EVALUATION OF A NEW ACTIVE FIXATION LEFT VENTRICULAR LEAD: RESULTS OF AN ITALIAN MULTICENTER EXPERIENCE.¿ EUROPACE. 2015. 17(SUP 3); III45. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FOR THE PATIENT WITH INFECTION: THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND SUBSEQUENT FOLLOW UP INFORMATION OBTAINED. THE INFORMATION WAS PREVIOUSLY SENT IN A REPORT ASSOCIATED WITH THE 3500A MEDWATCH REPORT NUMBER 3002807561-2015-00005, WHICH WAS SUBMITTED IN A TIMELY MANNER ON (B)(4). 2015. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. FOR THE PATIENT WITH LEAD DISLODGEMENT: THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND SUBSEQUENT FOLLOW UP INFORMATION OBTAINED. THE INFORMATION WAS PREVIOUSLY SENT IN A REPORT ASSOCIATED WITH THE 3500A MEDWATCH REPORT NUMBER 3002807561-2015-00024, WHICH WAS SUBMITTED IN A TIMELY MANNER ON (B)(4). 2015. ALL INFORMATION PROVIDED IS INCLUDED IN THIS 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 WHICH CONTAINED INFORMATION REGARDING AN ACTIVE FIXATION LEFT VENTRICULAR LEAD MODEL. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WAS ONE PATIENT WITH A LEAD DISLODGEMENT WHICH DID NOT REQUIRE INTERVENTION. THERE WAS ALSO ONE PATIENT WHO HAD THE LEAD REMOVED, WITHOUT ANY COMPLICATIONS, DUE TO INFECTION. THE STATUS/LOCATION OF THE LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THROUGH FOLLOW UP WITH THE AUTHOR WHO INDICATED THAT THE TWO PATIENTS WERE PREVIOUSLY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703798 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, PLC MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention IMPLANTABLE PULSE GENERATOR (IPG)