BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12616718 · Received October 12, 2021

    Report

    Report Number
    3006630150-2021-05717
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    July 26, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-50 (SN: (B)(6)) THE RETURNED LEAD WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2317-50 (SN: (B)(6)) THE RETURNED LEAD WAS ANALYZED AND THE COMPLAINT WAS CONFIRMED. FIVE CABLES WERE FRACTURED AT THE CLICK SITE, ABOUT 19 CENTIMETERS FROM THE DISTAL END. WHEN EXCESSIVE MECHANICAL/TENSILE FORCE WAS EXERTED ONTO THE LEAD, THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE CABLE FRACTURES, WHICH CAUSED THE REPORTED PATIENTS EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTACTS ON PATIENTS LEADS WERE HAVING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND WAS DOING GREAT POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS- LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7071300.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTACTS ON PATIENTS LEADS WERE HAVING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING GREAT POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510972 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7071246 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention