BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 20755115 · Received November 22, 2024

    Report

    Report Number
    3006630150-2024-08048
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    March 9, 2023
    Report Date
    November 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7070012. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7070590. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7071790. PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC11600. MODEL: SC-1160. SERIAL: (B)(6). BATCH: SC-1160.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED SENSITIVITY AND DISCOMFORT AT ONE OF HER TWO IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITES AND UNDERWENT A REVISION PROCEDURE (REPORTED IN MFR# 3006630150-2024-08047). DURING THE PROCEDURE IT WAS FOUND THAT THE LEADS FROM BOTH SYSTEMS HAD BECOME ENTANGLED. AS A RESULT, THE LEADS WERE REMOVED; AND DUE TO THE FACT THAT THE PHYSICIAN FELT THAT THERAPY NEEDS COULD BE ACCOMPLISHED WITH ONE SYSTEM THE IPG WAS ALSO REMOVED. THE PATIENT DID WELL POSTOPERATIVELY. IT WAS NOTED THAT THE PATIENT WORE A COMPRESSIVE GIRDLE, AND THE ACT OF PUTTING IT ON AND WEARING IT THE FULL DAY APPEARED TO HAVE PUSHED DOWN ON THE IPG WHICH MAY HAVE CAUSED THE DEVICES TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851727 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2366-50 7071973 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention