BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT LOW VOLTAGE LEAD

    MDR report key: 24796869 · Received April 7, 2026

    Report

    Report Number
    2017865-2026-07142
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ABBOTT MEDICAL (CRM-SYLMAR)
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. UDI IS NOT AVAILABLE AS PRODUCT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE HELIX OF THE LOW VOLTAGE LEAD FAILED TO EXTEND DESPITE THE HELIX LOCKING TOOL (HLT) BEING POSITIONED AT THE PROXIMAL END OF THE LEAD. TORQUE COULD NOT BE EFFECTIVELY TRANSMITTED TO THE DISTAL LEAD TIP. IT WAS UNKNOWN IF THE LEAD WAS REPLACED. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857537 ABBOTT LOW VOLTAGE LEAD No Match NVN ABBOTT MEDICAL (CRM-SYLMAR) LOW VOLTAGE LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown