BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 12461040 · Received September 13, 2021

    Report

    Report Number
    2182208-2021-03581
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    November 30, 2020
    Report Date
    September 13, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: LATE PRESENTATION OF RECURRENT SYNCOPE AFTER PERMANENT PACEMAKER IMPLANTATION DUE TO LEAD-HEADER MALPOSITION. INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL. 21 (2021) 124-127. DOI.ORG/10.1016/J.IPEJ.2020.11.019. 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 THIS LEAD. THE ARTICLE REPORTS A PATIENT WHO COMPLAINED OF INTERMITTENT LIGHTHEADEDNESS APPROXIMATELY ONE WEEK POST IMPLANT. THE PATIENT PRESENTED TO THE HOSPITAL WITH RECURRENT SYNCOPE APPROXIMATELY 14 MONTHS AFTER THE IMPLANT. PACEMAKER INTERROGATION RECORDED NOISE RESULTING IN RIGHT VENTRICULAR (RV) PACING INHIBITION. OVERSENSING WAS SUSPECTED AND POCKET MANIPULATION, DEEP INSPIRATION, VALSALVA MANEUVER, ARM ISOMETRICS, LEFT ARM EXTENSION, ABDUCTION AND ADDUCTION DID NOT DUPLICATE THE NOISE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED, AND THE PATIENT WAS TRANSFERRED FOR LEAD REVISION. DURING THE PROCEDURE, IT WAS REVEALED THAT THE RV LEAD TERMINAL PIN WAS NOT FULLY INSERTED INTO OR ENGAGED IN THE HEADER OF THE DEVICE. THE LEAD WAS REVISED WITH THE LEAD FULLY REINSERTED INTO THE HEADER AND BOTH SET SCREWS WERE TIGHTENED. THE STATUS/DISPOSITION OF THE LEAD APPEARS TO BE STILL IN USE. 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
    1359466 CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R K173 IPG, 5076 LEAD