BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12018522 · Received June 17, 2021

    Report

    Report Number
    3006630150-2021-03029
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 25, 2021
    Report Date
    October 10, 2021
    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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES AND POSSIBLE FRACTURE WAS NOTED. IT WAS ALSO MENTIONED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT WILL UNDERGO REVISION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS PER HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7073519.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES AND POSSIBLE FRACTURE WAS NOTED. IT WAS ALSO MENTIONED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT WILL UNDERGO REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912595 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5060234 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention