BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STABILITY

    MDR report key: 11690578 · Received April 19, 2021

    Report

    Report Number
    2182208-2021-01545
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 19, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDT CRTD 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/(B)(6) YEARS OLD. 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: PERFORMANCE OF AN ACTIVE FIXATION BIPOLAR LEFT VENTRICULAR LEAD VS PASSIVE FIXATION QUADRIPOLAR LEADS IN CARDIAC RESYNCHRONIZATION THERAPY, A RANDOMIZED TRIAL. JOURNAL OF ARRHYTHMIA. 2021;37:212¿218. DOI: 10.1002/JOA3.12450 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 ACTIVE AND PASSIVE FIXATION BIPOLAR LEFT VENTRICULAR (LV) QUADRIPOLAR LEADS. THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED PHRENIC NERVE STIMULATION WHICH WAS RESOLVED WITH REPROGRAMMING. THERE WERE LV LEAD DISLODGEMENTS THAT OCCURRED REPEATEDLY DURING IMPLANTATION AND POST IMPLANT. REPOSITIONING OR LEAD REPLACEMENT WAS PERFORMED. THE STATUS/DISPOSITION OF THE 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
    583949 ATTAIN STABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC, INC. 479688

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R