BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18384674 · Received December 22, 2023

    Report

    Report Number
    3006630150-2023-08085
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    April 19, 2023
    Report Date
    December 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR ST UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 228632. ARTG: 128775. BRAND NAME: NULL. UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7059428, ARTG: 205793. BRAND NAME: NULL. UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7071465, ARTG: 128679. BRAND NAME: NULL. UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7071523, ARTG: 128679. BRAND NAME: PRECISION SPECTRA. UPN: M365SC11320, MODEL: SC-1132, SERIAL: (B)(6), BATCH: 205511.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT REPORTED SHE WAS EXPERIENCING UNWANTED ZAPPING SENSATIONS IN HER HEAD, AND LOSS OF THERAPY. A SYSTEM CHECK REVEALED HIGH IMPEDANCES. AN ATTEMPT WAS MADE TO STIMULATE ON CONTACTS WITHOUT HIGH IMPEDANCES, HOWEVER THE STIMULATION WAS VERY UNCOMFORTABLE ACROSS BOTH LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE TWO SPINAL CORD STIMULATION (SCS) LEADS AND TWO LEAD EXTENSIONS WERE REPLACED, AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPOSITIONED TO THE RIGHT CHEST WALL PER PATIENT PREFERENCE FOR CHARGING LOCATION. IT IS NOT KNOWN WHICH TWO OF THE THREE EXTENSIONS WERE REPLACED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308113 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 A50561 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention