BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH LEAD ANCHOR

    MDR report key: 18320685 · Received December 13, 2023

    Report

    Report Number
    1627487-2023-05905
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 13, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    UDI-DI
    05415067024091
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE DEVICE INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ALLEGATION IS AGAINST 1 OF 2 ANCHOR; HOWEVER, IT IS UNKNOWN WHICH ANCHOR(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: ANCHOR, MODEL: 1194ANS, UDI: (B)(4), SERIAL: N/A, BATCH: 6192367.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-05904. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG AND ANCHOR SITE. SURGICAL INTERVENTION TOOK PLACE WHERE THE IPG AND ANCHOR WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE ANCHORS ATTRIBUTED TO THE EVENT. THE ALLEGATION IS AGAINST 1 OF 2 ANCHOR; HOWEVER, IT IS UNKNOWN WHICH ANCHOR(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: ANCHOR, MODEL: 1194ANS, UDI: (B)(4), SERIAL: N/A, BATCH: 6192367.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655421 CINCH LEAD ANCHOR SCS ANCHOR GZB ABBOTT MEDICAL 1194 6192367 05415067024091

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS ANCHOR| SCS LEAD (X2)