BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19140891 · Received April 18, 2024

    Report

    Report Number
    3006630150-2024-02460
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    March 8, 2023
    Report Date
    April 18, 2024
    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: 7077570. BRAND NAME: LINEAR ST. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7070847. BRAND NAME: N/A. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7060088. BRAND NAME: LINEAR ST. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 5139434. BRAND NAME: SPECTRA WAVEWRITER. UPN: M365SC11600. MODEL: SC-1160. SERIAL: (B)(6). BATCH: 362238. BRAND NAME: N/A. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7048089. BRAND NAME: LINEAR ST. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7070846.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) LEADS MIGRATED AND THE LEADS DISPLAYED HIGH IMPEDANCES. RE-PROGRAMMING WAS DONE TO HELP GET BETTER COVERAGE OF THEIR PAIN AREAS. THE PATIENT EXPERIENCED PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WHICH THE PHYSICIAN ATTRIBUTED TO THE LEADS HAVING MIGRATED AND BEING TANGLED THEREFORE WERE PULLING ON THE IPG. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY. OTHER THAN POST OPERATIVE PAIN DUE TO PROCEDURE, THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081218 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5073351 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention