BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL MRI

    MDR report key: 23500800 · Received November 7, 2025

    Report

    Report Number
    2017865-2025-1004431
    Event Type
    Injury
    Date Received
    November 7, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION FOR THIS EVENT WAS OBTAINED FROM A LITERATURE REVIEW ARTICLE: HEART RHYTHM CASE REPORTS, VOL 11, NO 10, OCTOBER 2025. PUBLISHED BY ELSEVIER INC. TITLED "WIRE IN PIGTAIL CATHETER THROUGH SNARE TWICE (WIPER TRUST) TECHNIQUE FOR GRASPING LEADS WITHOUT FREE ENDS IN TRANSVENOUS LEAD EXTRACTION". YUHEI KASAI, MD, FHRS, JUNJI MORITA, MD, TAKAYUKI KITAI, MD, TAKUYA HARAGUCHI, MD, TSUTOMU FUJITA, MD, KAZUHIRO SATOMI, MD, PHD. FROM THE DEPARTMENT OF CARDIOLOGY, ASIA MEDICAL GROUP, SAPPORO HEART CENTER, SAPPORO CARDIOVASCULAR CLINIC, SAPPORO, HOKKAIDO, JAPAN, AND DEPARTMENT OF CARDIOLOGY, TOKYO MEDICAL UNIVERSITY, SHINJUKU, TOKYO, JAPAN.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A LITERATURE REVIEW ARTICLE THAT A PACEMAKER EVALUATION SHOWED MULTIPLE EPISODES OF ELECTRICAL ARTIFACTS IN THE RIGHT VENTRICULAR (RV) LEAD (TENDRIL MRI, 52 CM, ABBOTT), WHILE THE RIGHT ATRIAL (RA) LEAD (TENDRIL MRI, 46 CM, ABBOTT) FUNCTIONED NORMALLY. THE PATIENT WAS SCHEDULED FOR TRANSVENOUS LEAD EXTRACTION (TLE), RV LEAD REPLACEMENT, AND PACEMAKER GENERATOR EXCHANGE. A LOCKING STYLET (LLD EZ, PHILIPS, AND OVER, MA) WAS ADVANCED TOWARD THE RV LEAD TIP, BUT THE HELIX COULD NOT BE UNSCREWED, AND FURTHER ADVANCEMENT WAS IMPEDED BY LEAD-TO-LEAD ADHESION AT THE INNOMINATE VEIN. THE DISTAL TIP OF THE RA LEAD BECAME DISLODGED FROM THE RA APPENDAGE, NECESSITATING ITS EXTRACTION. THE RA AND RV LEADS WERE EXTRACTED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. DETAILS ARE LISTED IN THE ARTICLE HEART RHYTHM CASE REPORTS, VOL 11, NO 10, OCTOBER 2025. PUBLISHED BY ELSEVIER INC. TITLED "WIRE IN PIGTAIL CATHETER THROUGH SNARE TWICE (WIPER TRUST) TECHNIQUE FOR GRASPING LEADS WITHOUT FREE ENDS IN TRANSVENOUS LEAD EXTRACTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172355 TENDRIL MRI No Match NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LPA1200M/52

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Required Intervention