BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD

    MDR report key: 18439888 · Received January 3, 2024

    Report

    Report Number
    1627487-2024-00066
    Event Type
    Injury
    Date Received
    January 3, 2024
    Report Date
    January 16, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS ESTIMATED.

    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 HAD MIGRATED CAUSING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD WAS EXPLANTED. MEDWATCH REPORT MW5148260 RECEIVED TO NMD COMPLAINTS ON 14DEC023. THE REASON FOR CALL WAS A WHILE AGO THE PATIENT HAD A STIMULATOR DONE BY ABBOTT AND IT MOVED AND WAS USELESS ON THEIR RIGHT SIDE. PATIENT HAD A BACK PROCEDURE WHERE THE STIMULATOR WAS IN THE WAY SO THEY REMOVED IT. PATIENT WAS TOLD BY THEIR DOCTOR THAT THEIR SYSTEM AND ABBOTT WERE VERY SIMILAR. PATIENT SAID THEY WERE TOLD THEY NEEDED DISCS 3 AND 4 SO THEY DID A SPINAL FUSION AND THAT WAS WHEN THEY REMOVED THE OTHER STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506913 OCTRODE LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL NMD0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other