BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS QUAD LEAD, 3/6MM, 60CM

    MDR report key: 21909507 · Received April 25, 2025

    Report

    Report Number
    1627487-2025-02005
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    March 29, 2025
    Report Date
    May 13, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. PATIENT¿S WEIGHT IS ESTIMATED. THE UDI COULD NOT BE PROVIDED BECAUSE THIS DEVICE WAS MANUFACTURED PRIOR TO BEING ASSIGNED AN UDI NUMBER. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. RECORDS INDICATES THAT THERE ARE FILINGS UNDER BOTH DEVICE PRODUCT CODE/ PMA NUMBERS: GZB/P010032 AND LGW/P010032.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT¿S LEAD WAS REPLACED DUE TO LEAD FRACTURE. REPORTEDLY, PATIENT HAD 3 LEAD REVISIONS DUE EITHER MIGRATION, FRACTURE OR REASON UNKNOWN (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2025-02004, 1627487-2025-02006).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477369 AXXESS QUAD LEAD, 3/6MM, 60CM SCS LEAD GZB ABBOTT MEDICAL 4156 29610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS IPG.