BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 9806808 · Received March 9, 2020

    Report

    Report Number
    2182208-2020-00468
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    October 1, 2017
    Report Date
    March 9, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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. THE BASELINE GENDER/AGE CHARACTERISTIC IS FEMALE/63 YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LEFT BUNDLE BRANCH PACING FOR SYMPTOMATIC BRADYCARDIA: IMPLANT SUCCESS RATE, SAFETY, AND PACING CHARACTERISTICS HEART RHYTHM 2019; 16:1758¿1765 HTTPS://DOI.ORG/10.1016/J.HRTHM.2019.05.014. 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 IMPLANTATION OF A PACING LEAD. THE INFORMATION SHOWED THERE WAS UNSUCCESSFUL LEFT BUNDLE BRANCH PACING IMPLANTATION IN SEVENTEEN PATIENTS DUE TO FAILURE OF THE LEAD TIP TO ADVANCE TO THE LEFT SIDE OF THE SEPTUM. THE AUTHORS NOTED A POTENTIAL CAUSE AS DUE TO LOCAL HYPERTROPHIED MYOCARDIUM. ONE PATIENT WHO WAS RECEIVING DUAL AN TIPLATELET THERAPY DEVELOPED A POCKET HEMATOMA AND ELEVEN PATIENTS DEVELOPED RIGHT BUNDLE BRANCH BLOCK DURING THE PROCEDURE THAT RESOLVED BEFORE DISCHARGE FROM THE HOSPITAL. THE STATUS/DISPOSITION OF THE LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268605 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 3830-69

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other