BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 6970202 · Received October 23, 2017

    Report

    Report Number
    2182208-2017-01813
    Event Type
    Injury
    Date Received
    October 23, 2017
    Date of Event
    March 7, 2017
    Report Date
    October 23, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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:ATRIAL UNDERSENSING SECONDARY TO QUIET TIMER BLANKING IN PEDIATRIC AND CONGENITAL HEART DISEASE PATIENTS. PACE - PACING AND CLINICAL ELECTROPHYSIOLOGY. 2017; 40(7):843-849. 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 PACING LEADS. FIVE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS ATRIAL LEAD UNDERSENSING SECONDARY TO QUIET TIMER BLANKING AS A RESULT OF ATRIAL AMPLIFIER SATURATION. THE PATIENTS ADDITIONALLY EXPERIENCED ELEVATED PACING THRESHOLDS. ONE PATIENT REQUIRED REPROGRAMMING THE VENTRICULAR LEAD PACING OUTPUT, TWO PATIENTS REQUIRED REPROGRAMMING OF THE RATE RESPONSE, AND ONE PATIENT REQUIRED A NEW SYSTEM IMPLANTED. THE STATUS OF THE LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749698 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R