BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 15100022 · Received July 25, 2022

    Report

    Report Number
    1627487-2022-04063
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 30, 2022
    Report Date
    September 23, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    UDI-DI
    05415067024084
    PMA / PMN Number
    K092371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE NUMBER 1627487-2022-04063, SHOULD NOT HAVE BEEN REPORTED AS A MEDICAL DEVICE REPORT (MDR) AS IT WAS REPORTED THAT IT IS THE LEAD THAT IS FRACTURED. LEAD FRACTURE IS DOCUMENTED IN MANUFACTURER REFERENCE NUMBER 3006705815-2022-16959.

    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 X-RAYS INDICATED THAT THERE WAS A SMALL FRACTURE ON THE DISTAL END OF THE ANCHOR. AS A RESULT, THERE WERE HIGH IMPEDANCES ON ALL CONTACTS AND STIMULATION WAS SUBSEQUENTLY LOST. IT WAS NOTED THAT PATIENT HAS A HIGHLY ACTIVE LIFESTYLE. SURGICAL INTERVENTION MAY BE CONSIDERED AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356232 SWIFT-LOCK ANCHOR SCS ANCHOR GZB ABBOTT MEDICAL 1192 8334305 05415067024084

    Patients

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