BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN CS

    MDR report key: 11667232 · Received April 14, 2021

    Report

    Report Number
    2182208-2021-01468
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    September 1, 2003
    Report Date
    April 14, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. 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 APPROXIMATELY 61 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. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: EFFECTIVE LONG-TERM LEFT ATRIAL PACING USING REGULAR SCREW-IN LEADS IMPLANTED WITHIN THE CORONARY SINUS. PACE. 2003; 26:1873¿1877.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING CORONARY SINUS (CS) LEADS. THE ARTICLE REPORTS PATIENTS IMPLANTED WITH PASSIVE FIXATION LEADS AND THE LEADS EXPERIENCED DISLODGEMENT. THE LEADS WERE REPOSITIONED WITHIN THE CS. CROSS TALK WAS DETECTED IN OTHER LEADS AND REPROGRAMMING WAS PERFORMED. THE STATUS/DISPOSITION OF THE LEADS IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565569 ATTAIN CS PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 2188

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R