BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18022724 · Received October 27, 2023

    Report

    Report Number
    3006630150-2023-06592
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    July 1, 2023
    Report Date
    January 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED LEAD SC-2317-70 SERIAL NUMBER (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE RETURNED LEAD SC-2317-70 SERIAL NUMBER (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE IFU PRODUCT LABEL. ADDITIONALLY, IT STATES LEAD MIGRATION RESULTING IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7081225.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION WHEREIN CAUSING A LOSS OF STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION WHEREIN CAUSING A LOSS OF STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207474 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7080238 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention