BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 12196648 · Received July 20, 2021

    Report

    Report Number
    2182208-2021-02883
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    September 26, 2020
    Report Date
    July 20, 2021
    Manufacturer
    MEDTRONIC, INC.
    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. 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. 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 SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/80 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: OUTCOMES OF SINGLE-LEAD VDD PACEMAKERS IN ATRIOVENTRICULAR BLOCKS: THE OSCAR STUDY. INTERNATIONAL JOURNAL OF CARDIOLOGY. 2021. 325; 62¿68. DOI.ORG/10.1016/J.IJCARD.2020.09.063. 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 PACEMAKERS IN ATRIOVENTRICULAR BLOCKS. THE ARTICLE REPORTS PATIENTS IMPLANTED WITH IMPLANTABLE PULSE GENERATORS (IPG) WHO EXPERIENCED INFECTION, POCKET HEMATOMA/DECUBITUS, PARTIAL WOUND DEHISCENCE, AND PACEMAKER SYNDROME. THERE WERE LEADS WHICH EXHIBITED LOSS OF ATRIAL SENSING, DISLODGEMENT, HIGH THRESHOLDS, PACING DEFECTS, ABNORMAL IMPEDANCE, POLARITY SWITCHES, AND LEAD FRACTURE WHICH REQUIRED REVISIONS. THE STATUS/DISPOSITION OF THE DEVICES AND LEADS IS UNKNOWN. NO FURTHER 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
    1096200 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R UNKNOWN IPG