BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN PERFORMA S MRI SURESCAN

    MDR report key: 10770771 · Received November 2, 2020

    Report

    Report Number
    6000030-2020-00227
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    January 1, 2020
    Report Date
    November 2, 2020
    Manufacturer
    RICE CREEK MFG
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEADS WERE EXPLANTED DUE TO HEART TRANSPLANTATION. THE INTENTION WAS TO RECANALIZE THE STENOTIC VEINS, HOWEVER, SINCE THE LEADS HAD BEEN REMOVED DURING THE HEART TRANSPLANT PROCEDURE, THERE WAS NO "RAIL" AVAILABLE TO AID IN CROSSING THE STENOSIS WITH A WIRE. RECANALIZATION OF THE VEINS WAS NOT POSSIBLE. CONCOMITANT MEDICAL PRODUCTS: EXACT DEVICE MODEL NUMBER WAS NOT PROVIDED. 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 EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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 AND NO FURTHER INFORMATION WAS MADE AVAILABLE. IF NEW INFORMATION IS LATER RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: TRANSVENOUS LEAD EXTRACTION AFTER HEART TRANSPLANTATION: HOW TO AVOID ABANDONED LEAD FRAGMENTS. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2020; 31:854-859. DOI: 10.1111/JCE.14393. 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 TRANSVENOUS LEAD EXTRACTIONS FOR HEART TRANSPLANTATIONS AND HOW TO AVOID ABANDONED LEAD FRAGMENTS. IT WAS REPORTED THAT A PATIENT PRESENTED WITH SYMPTOMATIC VENOUS STASIS DUE TO SUPERIOR VENA CAVA STENOSIS. THE VENOUS STENOSIS WAS THOUGHT TO HAVE BEEN CAUSED BY LONG-TERM CHRONICALLY IMPLANTED LEADS. THE LEADS WERE REMOVED DUE TO HEART TRANSPLANT. INTERVENTION TO RECANALIZE THE STENOTIC VEINS WAS NOT POSSIBLE SINCE THE LEADS WERE REMOVED INTRAOPERATIVELY. THE LEADS TYPICALLY ACT AS THE RAIL FOR RECANALIZATION. SINCE THE LEADS WERE REMOVED, THE RAIL WAS LOST SO THE CLINICIAN WAS UNABLE TO CROSS STENOSIS WITH A WIRE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235350 ATTAIN PERFORMA S MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX RICE CREEK MFG 459878

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other VIVA QUAD XT CRTD, 6947M LEAD, 4076 LEAD