BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 9213728 · Received October 21, 2019

    Report

    Report Number
    2182208-2019-01876
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    January 1, 2013
    Report Date
    October 21, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A PRODUCT 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: TRANSVENOUS EXTRACTION OF AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEAD LOOPED AND DAMAGED IN SUBCLAVIAN VEIN. KARDIOLOGIA POLSKA. 2013; 71(12):1328. DOI: 10.5603/KP.2013.0340. 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 A CASE OF A LEAD LOOPING AND DAMAGING A SUBCLAVIAN VEIN. IT WAS REPORTED THAT AN X-RAY WAS PERFORMED POST IMPLANT OF A COMPETITOR LEAD INTO THE RIGHT ATRIUM (RA) AND THE RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED TO BE "LOOPING" IN THE LEFT SUBCLAVIAN VEIN AND A "PULLING-UP" IN THE HEART CAVITIES WAS OBSERVED. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND TRICUSPID REGURGITATION WAS OBSERVED WHICH WAS FOUND TO BE RELATED TO PRESSURE ON THE SEPTALCUSP OF THE TRICUSPID VALVE BY THE STRETCHED VENTRICULAR LEAD. IT WAS CONFIRMED VIA LEFT SUBCLAVIAN VEIN VENOGRAPHY THAT THERE WAS A VENTRICULAR LEAD LOOP OUTLINING THE VESSEL LUMEN WITH THE ATRIAL LEAD EXISTING INSIDE THIS LOOP. DURING THE RV LEAD EXTRACTION, THE LEAD WAS FOUND TO BE ADHERED TO THE SUBCLAVIAN VEIN WALL AND DIFFICULTY WAS EXPERIENCED INSERTING THE GUIDEWIRE/STYLET DUE TO THE LEAD LOOPING, BUT THE LEAD WAS SUCCESSFULLY EXPLANTED NONETHELESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009704 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6932

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R