BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMODULATION DEVICE

    MDR report key: 20347700 · Received October 1, 2024

    Report

    Report Number
    2182207-2024-04064
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Report Date
    October 1, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: HE Q, YANG C, XU Y, ET AL. ANATOMICAL-RELATED FACTORS AND OUTCOME OF PERCUTANEOUS SHORT-TERM SPINAL CORD STIMULATION ELECTRODE SHIFT IN PATIENTS WITH DISORDERS OF CONSCIOUSNESS: A RETROSPECTIVE STUDY. FRONT AGING NEUROSCI. 2024;16:1403156. DOI :10.3389/FNAGI.2024.1403156 D2: PLEASE NOTE THE DEVICES USED IN THE ARTICLE WERE USED FOR AN OFF LABEL INDICATION - TREATMENT OF DISORDERS OF CONSCIOUSNESS. CONTINUATION OF D10: PRODUCT ID 3777, LOT# UNKNOWN, PRODUCT TYPE LEAD, UBD: ASKU, UDI#: ASKU. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 PATIENTS UNDERWENT PERCUTANEOUS SHORT-TERM SPINAL CORD STIMULATION (SCS) FOR THE TREATMENT OF DISORDERS OF CONSCIOUSNESS (DOC). THE PATIENTS EXPERIENCED AN AVERAGE ELECTRODE SHIFT OF 4.38 MM ACROSS THE ENTIRE SAMPLE GROUP, WHERE THE AUTHORS NOTED THAT ¿A LINEAR CORRELATION WAS FOUND BETWEEN THE LENGTH OF ELECTRODE SHIFT AND PATIENTS¿ OUTCOME, WITH LONGER SHIFT LENGTHS ASSOCIATED WITH POORER OUTCOMES.¿ THE PATIENTS WERE CATEGORIZED BY ELECTRODE SHIFT IN GROUPS OF LESS ELECTRODE SHIFT (13 PATIENTS) AND MORE ELECTRODE SHIFT (12 PATIENTS). THE VARYING SEVERITIES OF ELECTRODE SHIFT WERE REPORTED TO HAVE HAD ¿A DIRECT AND ADVERSE IMPACT ON THE SHORT-TERM THERAPEUTIC EFFICACY OF SCS IN PATIENTS WITH DISORDERS OF CONSCIOUSNESS.¿ THE PATIENTS WERE SUBSEQUENTLY CATEGORIZED BY OUTCOME AS GOOD (6 PATIENTS), FAIR (11 PATIENTS), AND POOR (8 PATIENTS). PATIENTS WERE ALSO CATEGORIZED BASED ON WHETHER THEY DEVELOPED POSTOPERATIVE PAROXYSMAL SYMPATHETIC HYPEREXCITABILITY (PSH). THE PATIENTS WERE CATEGORIZED INTO THE FOLLOWING GROUPS: NO POSTOPERATIVE PSH GROUP (12 PATIENT), MILD POSTOPERATIVE PSH GROUP (9 PATIENTS) AND SEVERE POSTOPERATIVE PSH GROUP (4 PATIENTS). DUE TO THE SHORT-TERM NATURE OF THE STUDY, THE PATIENTS UNDERWENT STIMULATION FOR 14 DAYS AND THEN HAD THE ELECTRODE REMOVED. THERE WERE NO SURGICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369616 NEUROMODULATION DEVICE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."