BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 9717901 · Received February 17, 2020

    Report

    Report Number
    2182208-2020-00310
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    January 1, 2008
    Report Date
    February 17, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE OVERALL BASELINE GENDER/AGE CHARACTERISTICS IS MALE/(B)(6) YEARS OLD. THE MODEL REPRESENTED IN THIS REPORT IS A REPRESENTATIVE OF POSSIBLE MODELS INVOLVED. POSSIBLE MODELS COULD INCLUDE THE 4074, 5076, IMK49B, AND/OR ICQ09B PRODUCTS. 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 WAS MADE TO NO AVAIL. IF NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LONG-TERM PERFORMANCE OF RIGHT VENTRICULAR PACING LEADS: RISK FACTORS ASSOCIATED WITH PERMANENT RIGHT VENTRICULAR PACING THRESHOLD INCREASE. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2019; 3:349-357. DOI: 10.1007/S10840-018-0481-5. 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 THE LONG TERM PERFORMANCE OF RIGHT VENTRICULAR (RV) LEAD AND THE RISK FACTORS ASSOCIATED WITH THRESHOLD INCREASE. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. IT WAS REPORTED THAT SOME OF THE PATIENTS EXPERIENCED A VARIETY OF ADVERSE EVENTS SUCH AS PNEUMOTHORAX, POCKET HEMATOMA, HAEMOTHORAX, AND INFECTION. THROUGHOUT THE STUDY, IMPLANTED RV LEADS EXHIBITED AN INCREASE IN THRESHOLDS. ADDITIONALLY, SOME OF THE LEADS HAD FRACTURED OR DISLODGED. REPROGRAMMING TYPICALLY OCCURRED AT ONE-MONTH FOLLOW UP POST IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180445 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R