BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCS LEAD

    MDR report key: 12703781 · Received October 27, 2021

    Report

    Report Number
    1627487-2021-17967
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    April 7, 2021
    Report Date
    December 15, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF INEFFECTIVE STIMULATION/NON-FUNCTIONAL SCS WAS CONFIRMED. BOTH LEADS WERE RETURNED COMPLETE. MICROSCOPIC INSPECTION IDENTIFIED A KINK IN THE LEAD BODY WHERE ALL OF THE INTERNAL WIRES WERE BROKEN. THIS WOULD HAVE CAUSED THE REPORTED ISSUE IN THE FIELD. THE FRACTURED WIRES ARE CONSISTENT WITH THE LEAD MAY HAVE BEEN SUBJECTED TO OVERSTRESS WHILE IN VIVO.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF INEFFECTIVE STIMULATION/NON-FUNCTIONAL SCS WAS CONFIRMED. THE OCTRODE LEAD WAS RETURNED COMPLETE BUT CUT IN TWO PIECES DUE TO THE EXPLANT PROCEDURE. MICROSCOPIC INSPECTION IDENTIFIED A KINK IN THE LEAD BODY WHERE ALL OF THE INTERNAL WIRES WERE BROKEN. THIS WOULD HAVE CAUSED THE REPORTED ISSUE IN THE FIELD. THE FRACTURED WIRES ARE CONSISTENT WITH THE LEAD BEING SUBJECTED TO OVERSTRESS WHILE IN VIVO.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17966, 1627487-2021-18143.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT AND DEVICE INFORMATION. THE UNIQUE DEVICE IDENTIFIER (UDI #) IS UNKNOWN BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17966. IT WAS REPORTED THE PATIENT'S SYSTEM WAS EXPLANTED. REASON FOR EXPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604460 SCS LEAD SCS LEAD LGW ABBOTT MEDICAL NMD0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other MODEL 3416 IPG| MODEL 3416 IPG| NMD0002 LEAD| MODEL 3416 IPG