BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18327498 · Received December 14, 2023

    Report

    Report Number
    3006630150-2023-07847
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    March 18, 2020
    Report Date
    December 14, 2023
    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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6) BATCH: 5040017 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC11600 MODEL: SC-1160 SERIAL: (B)(6) BATCH: 362767

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED RESULTING IN LOSS OF COVERAGE OF PAIN AREAS DESPITE REPROGRAMMING. IT WAS ALSO NOTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES AND THE PATIENT EXPERIENCED DIFFICULTY CHARGING OF THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273660 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5039824 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention